TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

81002

TEST NAME
Dipstick or tablet reagent urinalysis non-automated for bilirubin, glucose, hemoglobin, ketone, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogen

MANUFACTURER
Various

USE
Screening of urine to monitor/diagnose various diseases/conditions, such as diabetes, the state of the kidney or urinary tract, and urinary tract infections

81025 82270 82272 (Contact your Medicare carrier for claims instructions.) 82962

Urine pregnancy tests by visual color comparison Fecal occult blood

Various Various

Diagnosis of pregnancy Detection of blood in feces from whatever cause, benign or malignant (colorectal cancer screening)

Blood glucose by glucose monitoring devices cleared by the FDA for home use Hemoglobin by copper sulfate nonautomated Ovulation tests by visual color comparison for human luteinizing hormone Blood count; spun microhematocrit Erythrocyte sedimentation rate nonautomated

Various

Monitoring of blood glucose levels

83026 84830

Various Various

Monitors hemoglobin level in blood Detection of ovulation (optimal for conception)

85013 85651

Various Various

Screen for anemia Nonspecific screening test for inflammatory activity, increased for majority of infections, and most cases of carcinoma and leukemia

This list includes updates from Change Request 7266

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

80047QW, 82330QW, 82374QW, 82435QW, 82565QW, 82947QW, 82950QW, 82951QW, 82952QW, 84132QW, 84295QW, 84520QW, 85014QW 80048QW

TEST NAME
Abbott i-STAT Chem8+ Cartridge {Whole Blood}

MANUFACTURER
i-STAT Corporation

USE
Measures ionized calcium, carbon dioxide, chloride, creatinine, glucose, potassium, sodium, urea nitrogen, and hematocrit in whole blood

1.

Abaxis Piccolo Blood Chemistry Analyzer (Basic Metabolic Reagent Disc){Whole Blood} Abaxis Piccolo xpress Chemistry Analyzer (Basic Metabolic Reagent Disc){Whole Blood} Abaxis Piccolo Blood Chemistry Analyzer (Electrolyte Metabolic Reagent Disc){Whole Blood} Abaxis Piccolo xpress Chemistry Analyzer (Electrolyte Metabolic Reagent Disc){Whole Blood} Abaxis Piccolo Blood Chemistry Analyzer (Comprehensive Metabolic Reagent Disc){Whole Blood} Abaxis Piccolo xpress Chemistry Analyzer (Comprehensive Metabolic Reagent Disc){Whole Blood}

Abaxis, Inc

Measures total calcium, carbon dioxide, chloride, creatinine, glucose, potassium, sodium, and urea nitrogen in whole blood

2.

Abaxis, Inc

80051QW

1.

Abaxis, Inc.

Measures carbon dioxide, chloride, potassium, and sodium in whole blood

2.

Abaxis, Inc.

80053QW

1.

Abaxis, Inc.

Measures alanine amino transferase, aspartate amino transferase, albumin, total bilirubin, total calcium, carbon dioxide, chloride, creatinine, glucose, alkaline phosphatase, potassium, total protein, sodium, and urea nitrogen in whole blood

2.

Abaxis, Inc.

This list includes updates from Change Request 7266 * Newly added waived test system

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

80061QW, 82465QW (Contact your Medicare carrier for claims instructions.), 83718QW, 84478QW

TEST NAME
1. Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole Blood)

MANUFACTURER
Abaxis, Incorporated

USE
Measures total cholesterol, HDL cholesterol, and triglycerides in whole blood

2.

Infopia USA LipidPro lipid profile and glucose measuring system (LipidPro Lipid Profile test strips) Piccolo Point of Care Chemistry Analyzer (Lipid Panel Reagent Disc) (Whole Blood) Polymer Technology Systems CardioChek PA Analyzer {PTS Panels Lipid Panel Test Strips}

Infopia Co., Ltd.

3.

Abaxis, Incorporated

4.

Polymer Technology Systems, Inc. Cholestech Corp. Measures alanine aminotransferase, total cholesterol, HDL cholesterol, and triglycerides in whole blood

80061QW, 82465QW (Contact your Medicare carrier for claims instructions.), 83718QW, 84460QW, 84478QW 80069QW

Cholestech LDX (Lipid Profile ALT (GPT)){Whole Blood}

1.

Abaxis Piccolo Blood Chemistry Analyzer (Piccolo Renal Function Panel){Whole Blood} Abaxis Piccolo xpress Chemistry Analyzer (Piccolo Renal Function Panel){Whole Blood}

Abaxis, Incorporated

Measures albumin, total calcium, total carbon dioxide, chloride, creatinine, glucose, phosphorus, potassium, sodium and urea nitrogen in whole blood

2.

Abaxis, Incorporated

This list includes updates from Change Request 7266 * Newly added waived test system

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

G0434QW (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.) G0434QW (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.)

TEST NAME
Phamatech QuickScreen One Step Amphetamine Test

MANUFACTURER
Phamatech

USE
Screening test for the presence/detection of amphetamine in urine

1.

Accu-Stat Drugs of Abuse Home Test for Marijuana (THC)

Accu-Stat Diagnostics, Inc.

Screening test for the presence/detection of cannabinoids (THC) in urine

2. 3. 4. 5. 6. 7.

ADC CLIA Waived Marijuana (THC) Test First Check Diagnostics LLC, First Check Home Drug Test Marijuana Phamatech QuickScreen One Step THC Screening Test Phamatech At Home Drug Test (Model 9078) Phamatech At Home Drug Test (Model 9078T) Worldwide Medical Corporation, First Check Home Drug Test (THC) Phamatech At Home Drug Test (Model 9073)

Advantage Diagnostics Corporation (ADC) ACON Laboratories, Inc. Phamatech Phamatech Phamatech Worldwide Medical Corporation Phamatech Screening test for the presence/detection of cocaine metabolites in urine

G0434QW (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.)

1.

This list includes updates from Change Request 7266 * Newly added waived test system

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

G0434QW(cont.) (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.)

TEST NAME
2. Phamatech At Home Drug Test (Model 9073T)

MANUFACTURER
Phamatech

USE
Screening test for the presence/detection of cocaine metabolites in urine

3. G0434QW (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.) 1.

Phamatech QuickScreen One Step Cocaine Screening Test Phamatech At Home Drug Test (Model 9068)

Phamatech Phamatech Screening test for the presence/detection of methamphetamines in urine

2. G0434QW (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.) 1.

Phamatech QuickScreen One Step Methamphetamine Test DyanGen NicCheck II Test Strips

Phamatech DynaGen, Inc. Detects nicotine and/or its metabolites in urine, which is used as an aid in indicating the smoking status of an individual and as an aid in the identification of a smoker as a low or high nicotine consumer

2. G0434QW (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.) 1.

Mossman Associates, Inc. NicCheck I Test Strips Phamatech At Home Drug Test (Model 9083)

Mossman Associates, Inc. Phamatech Screening test for the presence/detection of opiates in urine

2.

Phamatech QuickScreen One Step Opiate Screening Test

Phamatech

This list includes updates from Change Request 7266 * Newly added waived test system

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

G0434QW (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.)

TEST NAME
1. Phamatech At Home Drug Test (Model 9133)

MANUFACTURER
Phamatech

USE
Screening test for the presence/detection of phencyclidine (PCP) in urine

2. G0434QW (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.) 1.

Phamatech QuickScreen One Step PCP Screening Test Accu-Stat Drugs of Abuse Home Test for Marijuana (THC) and Cocaine (COC)

Phamatech Accu-Stat Diagnostics, Inc. Screening test for the presence/detection of cannabinoids (THC) and cocaine metabolites in urine

2.

Advantage Diagnostics Advantage Marijuana (THC) and Cocaine Home Drug Test ADC CLIA Waived Marijuana (THC) and Cocaine Test Forefront Diagnostics Drugfree@Home THC/COC Test Kit Worldwide Medical Corporation, First Check Home Drug Test (THC-COC) Alfa Scientific Designs, Inc. Instant-View Drug of Abuse Urine Cassette Test

ADC

3. 4.

ADC Forefront Diagnostics, Inc.

5.

Worldwide Medical Corporation Alfa Scientific Designs, Inc. Screening test for the presence/detection of morphine and oxycodone in urine

G0434QW (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.)

1.

This list includes updates from Change Request 7266 * Newly added waived test system

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

G0434QW (cont.)(This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.) G0434QW (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.)

TEST NAME
2. Alfa Scientific Designs, Inc. Instant-View Drug of Abuse Urine Cup Test

MANUFACTURER
Alfa Scientific Designs, Inc.

USE
Screening test for the presence/detection of morphine and oxycodone in urine

1.

ADC CLIA Waived Multiple Drug Test Card

ADC

Screening test for the presence/detection of cannabinoids (THC), cocaine metabolites, methamphetamines, opiates, and PCP in urine

2. 3. G0434QW (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.) G0434QW (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.)

Advantage Diagnostics Corporation ADC Multiple Drug Test Card Alatex Scientific Peace of Mind Multiple Drugs of Abuse Test

Advantage Diagnostics Corporation Advantage Diagnostics Corporation Phamatech Screening test for the presence/detection of amphetamines, THC, cocaine metabolites, methamphetamines, and opiates in urine

Phamatech At Home Drug Test (Model 9150T)

Worldwide Medical Corporation, First Check Home Drug Test Panel 4 (THC-COC-OPI-MET)

Worldwide Medical Corporation

Screening test for the presence/detection of THC, cocaine metabolites, opiates and methamphetamines in urine

This list includes updates from Change Request 7266 * Newly added waived test system

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

G0434QW (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.)

TEST NAME
1. Accu-Stat Drugs of Abuse Home Test for Marijuana, Cocaine, Amphetamine, Methamphetamines, Opiates and Phencyclidine

MANUFACTURER
Accu-Stat Diagnostics, Inc.

USE
Screening test for the presence/detection of amphetamines, THC, cocaine metabolites, methamphetamines, opiates, and PCP in urine

2. 3.

accutest Multi-Drug, Multi-Line Screen Test Device Acon One Step Multi-Drug, MultiLine Screen Test Device (Professional Use) Biotechnostix Rapid Response One Step Multi-Drug, Multi-Line Screen Test Device iCassette Multi-Drug, Multi-Line Screen Test Device RediScreen Multi-Drug, Multi-Line Screen Test Device Redwood Toxicology Laboratory Reditest 6 Cassette substance abuse screening device {Professional Use} Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup

ACON Laboratories, Inc. ACON Laboratories, Inc. Screening test for the presence/detection of amphetamines, THC, cocaine metabolites, methamphetamines, opiates, and PCP in urine

4.

ACON Laboratories, Inc.

5.

ACON Laboratories, Inc.

6. 7.

ACON Laboratories, Inc. Innovacon, Inc.

G0434QW (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.)

1.

ACON Laboratories, Inc.

Screening test for the presence/detection of amphetamines, THC, cocaine metabolites, methamphetamines, methylenedioxymethamphetamine (MDMA), opiates, and PCP in urine

This list includes updates from Change Request 7266 * Newly added waived test system

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

G0434QW (cont.)(This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.)

TEST NAME
2. Drug Detection Devices Ltd. MultiDrug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup

MANUFACTURER
Innovacon, Inc.

USE
Screening test for the presence/detection of amphetamines, THC, cocaine metabolites, methamphetamines, MDMA , opiates, and PCP in urine

3. 4. 5. 6.

First Check Diagnostics First Check Multi Drug Cup Innovacon Integrated E-Z Split Key Cup II {Professional Use} Noble Medical Inc. Split-Specimen Cup 1 Step Detect Associates DTX Drug Test Cup Integrated E-Z Split Key Cup II Quest Diagnostics Incorporated, Express Results Integrated MultiDrug Screen Cup {professional use} Wolfe Drug Testing RealityCheck Integrated Specimen Cup

First Check Diagnostics LLC Innovacon, Inc. ACON Laboratories, Inc. Biosite Inc.

7.

Innovacon, Inc.

8. G0434QW (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.)

Innovacon, Inc. Branan Medical Corporation Screening test for the presence/detection of amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, MDMA, opiates, oxycodone, and PCP in urine

Branan Medical Corporation ToxCup Drug Screen Cup

This list includes updates from Change Request 7266 * Newly added waived test system

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

G0434QW (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.)

TEST NAME
1. Innovacon Multi-Clin Drug Screen Test Device

MANUFACTURER
Innovacon, Inc.

USE
Screening test for the presence/detection of amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, MDMA, opiates, oxycodone, PCP, propoxyphene and tricyclic antidepressants in urine

2. 3. 4. G0434QW (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.) 1.

Inverness Medical Innovations Signify ER Drug Screen Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device Abbott Diagnostics Signify ER Drug Screen Test Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test

Biosite Inc. Innovacon, Inc. Innovacon, Inc. Alfa Scientific Designs, Inc. Screening test for the presence/detection of amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methamphetamines, methadone, MDMA, morphine, PCP and tricyclic antidepressants in urine

2.

Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Cup Test BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine) BTNX Inc. Rapid Response MultiDrug One Step Screen Test Panel (Urine) Confrim Biosciences Drugconfirm instant multi-drug test kit, MultiDrug of Abuse Urine Test* Insight Medical Multi-Drug of Abuse Urine Test* Micro Distributing II, Ltd MultiDrug of Abuse Urine Test*

Alfa Scientific Designs, Inc.

3. 4.

Alfa Scientific Designs, Inc. Alfa Scientific Designs, Inc.

5.

Alfa Scientific Designs, Inc.

6. 7.

Alfa Scientific Designs, Inc. Alfa Scientific Designs, Inc.

This list includes updates from Change Request 7266 * Newly added waived test system

10

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

G0434QW (cont.)(This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.)

TEST NAME
8. Millenium Laboratories Multi-Drug of Abuse Urine Test*

MANUFACTURER
Alfa Scientific Designs, Inc

USE
Screening test for the presence/detection of amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methamphetamines, methadone, MDMA, morphine, PCP and tricyclic antidepressants in urine

9.

Physicians Test Multi-Drug of Abuse Urine Test*

Alfa Scientific Designs, Inc. Alfa Scientific Designs, Inc. Alfa Scientific Designs, Inc. Alfa Scientific Designs, Inc. Alfa Scientific Designs, Inc

10. On the Spot Drug Testing MultiDrug of Abuse Urine Test * 11. Quik Test USA, Inc. Multi-Drug of Abuse Urine Test 12. Screen Tox Multi-Drug of Abuse Urine Test 13. Total Diagnostic Solutions MultiDrug of Abuse Urine Test* G0434QW (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.) 1. Aventir Biotech LLC Home Check Multiple Drug Test Cup

Tianjin New Bay Bioresearch Co. Ltd.

Screening test for the presence/detection of amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methamphetamines, methadone, morphine, oxycodone, PCP and tricyclic antidepressants in urine

2.

Aventir Biotech LLC Home Check Multiple Drug Cup Test {Professional version} Syntron Bioresearch Quikscreen Multiple Drug Cup Test {Professional version}

Tianjin New Bay Bioresearch Co. Ltd Tianjin New Bay Bioresearch Co. Ltd

3.

This list includes updates from Change Request 7266 * Newly added waived test system

11

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

G0434QW (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.)

TEST NAME
1. Amedica Biotech Amedica Drug Screen Test Cup

MANUFACTURER
Amedica Biotech, Inc.

USE
Screening test for the presence/detection of amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, MDMA, opiates, oxycodone, PCP and tricyclic antidepressants in urine

2. 3. 4.

Amedica Biotech AmediCheck Instant Test Cup* Ameditech, Inc ImmuTest Drug Screen Cup Branan Medical Corporation Fastect II Drug Screen Dipstick Test Branan Medical Corporation, FasTox Multiple Drug Dipcard Branan Medical Corporation, QuickTox Drug Screen Dipcard CLIAwaived, Inc. Rapid Drug Test Express Diagnostics, DrugCheck Waive Cup First Check Diagnostics First Check 12 Drug Test

Amedica Biotech, Inc.` Biosite Inc. Branan Medical Corporation

5. 6. 7. 8. 9.

Branan Medical Corporation Branan Medical Corporation Biosite Inc. Biosite Inc. First Check Diagnostics LLC Amedica Biotech, Inc Biosite Inc.

10. Jant Pharmacal Corporation ACCUTEST Drug Test Cup* 11. Millennium Laboratories Clinical Supply, Inc Multi-Drug Pain Med Screen Cup 12. NexScreen LLC, NexScreen Cup* 13. Noble Medical Inc. NOBLE 1 Step Cup {OTC}

Amedica Biotech, Inc. Biosite Inc.

This list includes updates from Change Request 7266 * Newly added waived test system

12

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

G0434QW(cont.) (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.)

TEST NAME
14. Redwood Toxicology Laboratory, Inc Reditest Freedom Cup

MANUFACTURER
Biosite Inc.

USE
Screening test for the presence/detection of amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, MDMA, opiates, oxycodone, PCP and tricyclic antidepressants in urine

15. Twin Spirit, Inc. DrugSmart Cup 16. US Diagnostics ProScreen Drugs of Abuse Cup {OTC} G0434QW (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.) 1. American Screening Corporation OneScreen Drug Test Cards

Biosite Inc. Biosite Inc. UCP Biosciences, Inc. Screening test for the presence/detection of amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, MDMA, methamphetamines, methadone, morphine, opiates, oxycodone, PCP, and tricyclic antidepressants in urine

2. 3. 4.

American Screening Corporation OneScreen Drug Test Cups American Screening Corporation Reveal Multi-Drug Testing Cups Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards Express Diagnostics International Inc. DrugCheck Waive Multiple Drug Screen Cups UCP Biosciences, Inc. Drug Screening Test Cards* UCP Biosciences, Inc. Multiple Drug Screen Cups* UCP Biosciences, Inc., UCP Home Drug Screening Test Cards

UCP Biosciences, Inc. UCP Biosciences, Inc UCP Biosciences, Inc.

5.

UCP Biosciences, Inc.

6. 7. 8.

UCP Biosciences UCP Biosciences UCP Biosciences, Inc.

This list includes updates from Change Request 7266 * Newly added waived test system

13

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

G0434QW (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.) 80178QW

TEST NAME
American Bio Medica Rapid TOX

MANUFACTURER
American Bio Medica Corp.

USE
Screening test for the presence/detection of amphetamines, barbiturates, benzodiazepines, buprenorphine, THC, cocaine metabolites, MDMA, methamphetamines, methadone, opiates, oxycodone, PCP, propoxyphene, and tricyclic antidepressants in urine

ReliaLAB Inc. InstaRead Lithium System {fingerstick or venipuncture whole blood} 1. 2. Biosys Laboratories Optima Urine Anlayzer Chemstrip Mini UA qualitative dipstick for glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, leukocytes automated Cole-Talyor Marketing Inc. CTI120 Urine Strip Analyzer Consult diagnostics Urine Analyzer Henry Schein OneStepPlus Urine Analyzer Hypoguard Diascreen Urine Chemistry Analyzer Jant Pharmacal Corporation Accustrip URS Reader Physician Sales & Service, Inc. PSS Select Urine Analyzer Roche Diagnostics Urisys 1100 Urine Analyzer

Akers Laboratories, Inc.

Measures lithium blood levels in whole blood

81003QW

BioSys Laboratories, Inc. Boehringer Mannheim Corporation

Screening of urine to monitor/diagnose various diseases/conditions, such as diabetes, the state of the kidney or urinary tract, and urinary tract infections

3. 4. 5. 6. 7. 8. 9.

Acon Laboratories, Inc. BioSys Laboratories, Inc. Macherey-Nagel GmbH & Co., Kg. Hypoguard USA, Inc.

BioSys Laboratories, Inc. Roche Diagnostics Corp. Roche Diagnostics/Boehringer MannheimCorporation

10. Roche Diagnostics/Boehringer Mannheim Chemstrip 101 Urine Analyzer

This list includes updates from Change Request 7266 * Newly added waived test system

14

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

81003QW (cont.)

TEST NAME
11. Teco Diagnostics URITEK TC-101 Urine Strip Reader 12. ThermoBiostar PocketChem UA

MANUFACTURER
Teco Diagnostics ThermoBiostar Siemens Healthcare Diagnostics Inc. Siemens Healthcare Diagnostics

USE
Screening of urine to monitor/diagnose various diseases/conditions, such as diabetes, the state of the kidney or urinary tract, and urinary tract infections

81003QW, 82044QW, 82570QW 81003QW, 82044QW, 82570QW, 84703QW

Siemens Clinitek 50 Urine Chemistry Analyzer 1. Siemens Clinitek Status Urine Chemistry Analyzer

Screening of urine to monitor/diagnose various diseases/conditions, such as diabetes, the state of the kidney or urinary tract, and urinary tract infections; and the semi-quantitative measurement of albumin and creatinine in urine Screening of urine to monitor/diagnose various diseases/conditions, such as diabetes, the state of the kidney or urinary tract, and urinary tract infections; the semi-quantitative measurement of albumin and creatinine in urine; and the diagnosis of pregnancy

2. 3. 81007QW

Siemens, Clinitek Status+ Analyzer Siemens, Clinitek Status Connect System

Siemens Healthcare Diagnostics Siemens Healthcare Diagnostics Savyon/USA Detects catalase in urine which is associated with urinary tract infections (UTIs). White blood cells and some bacteria associated with UTIs are positive for catalase. Measures ketones in whole blood

Diatech Diagnostics Uriscreen (for OTC use) PTS Bioscanner (for OTC use) - for blood ketones 1. Abbott Laboratories, Medisense Products Precision Xtra Advanced Diabetes Management System (K983504) Abbott Medisense Precision Xtra Advanced Diabetes Management System (K040814) Nova Biomedical Nova Max Plus Glucose and B-Ketone Monitoring System

82010QW

Polymer Technology Systems, Inc. Abbott Laboratories

82010QW, 82962

Monitoring of blood glucose levels and measures ketones in whole blood

2.

Abbott Laboratories

3.

Nova Biomedical Corp.

This list includes updates from Change Request 7266 * Newly added waived test system

15

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

82040QW, 82150QW, 82247QW, 82977QW, 84075QW, 84155QW, 84450QW, 84460QW

TEST NAME
1. Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc){whole blood}

MANUFACTURER
Abaxis, Inc.

USE
Measures alanine aminotransferase, albumin, alkaline phosphatase, amylase, aspartate aminotransferase, gamma glutamyltransferase, total bilirubin and total protein levels in whole blood

2.

Abaxis Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood)

Abaxis, Inc

82040QW, 82310QW, 82565QW, 82947QW, 82950QW, 82951QW, 82952QW, 84520QW 82043QW 82044QW

Arkay SPOTCHEM EZ Chemistry Analyzer (Spotchem II Basicpanel 1) {Whole Blood}

Polymedco, Inc.

Measures albumin, total calcium, creatinine, glucose and total protein levels in whole blood

HemoCue Albumin 201 System 1. Beckman Coulter ICON Microalb

HemoCue, Inc. Beckman Coulter, Inc.

Quantitative measurement of albumin in urine by immunoassay Determination of low concentrations of albumin in urine by immunoassay, which is helpful for early detection in patients at risk for developing renal disease

2. 3.

Boehringer Mannheim Chemstrip Micral Diagnostic Chemicals ImmunoDip Urinary Albumin Test Diagnostic Chemicals ImmunoDip Urinary Albumin Screen (Urine Dipstick) Genzyme Daignostics OSOM ImmunoDip Urinary Albumin Test

Boehringer Mannheim Diagnostic Chemicals Limited Diagnostic Chemicals Limited (USA) Genzyme Diagnositcs

4.

5.

This list includes updates from Change Request 7266 * Newly added waived test system

16

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

82044QW(cont.)

TEST NAME
6. Roche Diagnostics Chemstrip Micral (urine dipstick)

MANUFACTURER
Roche Diagnostics Corporation Polymedco, Inc.

USE
Determination of low concentrations of albumin in urine by immunoassay, which is helpful for early detection in patients at risk for developing renal disease Measures alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, total bilirubin and urea levels in whole blood

82247QW, 84075QW, 84155QW, 84450QW, 84460QW 82055QW (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.)

Arkay SPOTCHEM EZ Chemistry Analyer (Spotchem II Basicpanel 2) {Whole Blood}

1.

OraSure Technologies Q.E.D. A150 Saliva Alcohol Test

OraSure Technologies, Inc.

Quantitative determination of alcohol (ethanol) in saliva

2. 3. 4.

OraSure Technologies Q.E.D. A350 Saliva Alcohol Test STC Diagnostics Q.E.D. A150 Saliva Alcohol Test STC Diagnostics Q.E.D. A350 Saliva Alcohol Test

OraSure Technologies, Inc. STC Technologies Inc. STC Technologies Inc.

82120QW, 83986QW

1. 2.

Litmus Concepts FemExam TestCard (from vaginal swab) Quidel QuickVue Advance pH and Amines Test Aerscher Hemaprompt FG SmithKline Gastroccult

Litmus Concepts, Inc. Quidel Corporation Aerscher Diagnostics SmithKline Beckman Coulter, Inc. Ind Diagnostic Inc.

Qualitative test of a vaginal fluid sample for elevated pH (pH greater than or equal to 4.7) and the presence of volatile amines

82271QW 82271QW, 83986QW 82274QW G0328QW

1. 2.

Rapid screening test to detect the presence of gastric occult blood Rapid screening test to detect the presence of gastric occult blood Rapid screening test to detect the presence of gastric occult blood and determine the pH (acid-base balance) of gastric aspirates Detection of blood in feces from whatever cause, benign or malignant (colorectal cancer screening) by immunoassay

Beckman Coulter Primary Care Diagnostics Gastrocult 1. American IVD Biotechnology Services Inc. FOB/CRC Advanced+*

This list includes updates from Change Request 7266 * Newly added waived test system

17

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

82274QW G0328QW(cont.)

TEST NAME
2. 3. 4. 5. Beckman Coulter Hemoccult ICT (K961062) & (K080812) BTNX Inc. Know Fecal Occult Blood (FOB) Self Test BTNX Inc. Rapid Response Fecal Immunochemical Test (FIT)* BTNX Inc. Rapid Response Immunological Fecal Occult Blood Test (IFOBT) BTNX Inc. Rapid Response Fecal Occult Blood (FOB) Self Test Care Diagnostics Clarity IFOB Test Clarity Hemosure One-Step Immunological Fecal Occult Blood Test Clearview Ultra FOB Test

MANUFACTURER
Beckman Coulter, Inc. Alfa Scientific Designs, Inc. Ind Diagnostic Inc. Teco Diagnostics

USE
Detection of blood in feces from whatever cause, benign or malignant (colorectal cancer screening) by immunoassay

6. 7. 8.

Alfa Scientific Designs, Inc Care Diagnostics, Inc. Wampole Laboratories

9.

RAC Medical Group, Inc. Immunostics, Inc.

10. Consult Diagnostics Immunochemical Fecal Occult Blood Test (iFOBT) 11. Enterix InSure Fecal Occult Blood Test 12. Enterix InSure Fecal Immunochemical Test 13. Enterix Insure II Fecal Immunochemical Test 14. Germaine Laboratories AimStep Immunological Fecal Occult Blood Test (iFOBT) 15. Germaine Laboratories Compliance Gold iFOB (immunological fecal occult blood) Test 16. Henry Schein One Step+ iFOBT 17. immoCare Fecal Occult Blood Test This list includes updates from Change Request 7266 * Newly added waived test system

Enterix, Inc. Enterix, Inc. Enterix, Inc. New Bay Bioresearch Co. Ltd. New Bay Bioresearch Co. Ltd. Immunostics, Inc. Care Diagnostic, Inc.

18

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

82274QW G0328QW(cont.)

TEST NAME
18. Immunostics, Inc., hema-screen Specific Immunochemical Fecal Occult Blood Test 19. InSure Quik Fecal Immunochemical Test (F.I.T.) 20. Inverness Medical Clearview iFOBT Complete Fecal Occult Blood Test 21. Jant Pharmacal Accutest Immunological Fecal Occult Blood Test (iFOBT) 22. OcculTech Fecal Occult Blood Rapid Test 23. Teco Rapid Fecal Occult Blood (FOB) Card Test

MANUFACTURER
Immunostics, In

USE
Detection of blood in feces from whatever cause, benign or malignant (colorectal cancer screening) by immunoassay

Enterix, Inc. New Bay Research Co. Ltd.

New Bay Bioresearch Co. Ltd. YD Diagnositcs Corp. Teco Diagnostics Abaxis, Inc. Measures chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide and urea nitrogen (BUN) in whole blood

82374QW, 82435QW, 82550QW, 82565QW, 82947QW, 84132QW, 84295QW, 84520QW

1.

Abaxis Piccolo Blood Chemistry Analyzer (Piccolo Metlyte 8 Panel Reagent Disc) {Whole Blood}

2.

Abaxis Piccolo xpress Chemistry Analyzer (Piccolo Metlyte 8 Panel Reagent Disc) {Whole Blood}

Abaxis, Inc

82435QW, 82947QW, 82950QW, 82951QW, 82952QW, 84132QW, 84295QW, 84520QW, 85014QW

Abbott i-STAT 6+ Cartridge {Whole Blood}

i-Stat Corporation

Measures chloride, glucose, potassium, sodium, urea nitrogen, and hematocrit in whole blood

This list includes updates from Change Request 7266 * Newly added waived test system

19

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

82465QW (Contact your Medicare carrier for claims instructions.)

TEST NAME
1. Advanced Care

MANUFACTURER
Johnson & Johnson

USE
Cholesterol monitoring

2. 3. 4. 5. 6. 7. 8.

Boehringer Mannheim Accu-Chek InstantPlus Cholesterol ChemTrak AccuMeter ENA.C.T Total Cholesterol Test ActiMed Laboratories ENA.C.T. Total Cholesterol Test (PDU) Lifestream Technologies Cholesterol Monitor Lifestream Technologies Personal Cholesterol Monitor Polymer Technology Systems (PTS) MTM Bioscanner 1000 (for OTC use) for cholesterol PTS Bioscanner Test Strips Chloesterol

Boehringer Mannheim ChemTrak ActiMed Laboratories, Inc. ActiMed Laboratories, Inc. Lifestream Technologies, Inc. Lifestream Technologies, Inc. Polymer Technology Systems, Inc. Polymer Technology Systems, Inc.

9.

82465QW (Contact your Medicare carrier for claims instructions.), 83718QW

1.

Polymer Technology Systems CardioChek Brand Analyzer (PTS Panels CHOL+HDL Panel Test Strips) Polymer Technology Systems CardioChek PA Analyzer (PTS Panels CHOL+HDL Panel Test Strips)

Polymer Technology Systems, Inc.

Measures total cholesterol and HDL cholesterol in whole blood

2.

Polymer Technology Systems, Inc.

Polymer Technology Systems Cardiochek PA Analyzer (PTS Panels CHOL+HDL Test Panel Test Strips) This list includes updates from Change Request 7266 * Newly added waived test system

3.

Polymer Technology Systems, Inc.

20

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

82465QW (Contact your Medicare carrier for claims instructions.), 82962

TEST NAME
1. Polymer Technology Systems Cardiochek PA Analyzer (PTS Panels Chol + Glu Test Panel)

MANUFACTURER
Polymer Technology Systems, Inc.

USE
Measures total cholesterol and monitors blood glucose levels

2.

Roche Diagnostics AccuChek Instant Plus Dual Testing System

82465QW (Contact your Medicare carrier for claims instructions.), 83718QW, 82947QW, 82950QW, 82951QW, 82952QW

1.

Polymer Technology Systems CardioChek Brand Analyzer (PTS Panels CHOL+HDL+GLUC Panel Test Strips)

Polymer Technology Systems, Inc.

Measures total cholesterol, HDL cholesterol, and glucose in whole blood

2.

Polymer Technology Systems CardioChek PA Analyzer (PTS Panels CHOL+HDL+GLUC Panel Test Strips) Cholestech LDX

Polymer Technology Systems, Inc.

82465QW (Contact your Medicare carrier for claims instructions.), 83718QW, 84478QW, 82947QW, 82950QW, 82951QW, 82952QW, 80061QW

1.

Cholestech Corp.

Measures total cholesterol, HDL cholesterol, triglycerides, and glucose in whole blood

2.

Infopia USA LipidPro lipid profile and glucose measuring system

Infopia CO., Ltd.

This list includes updates from Change Request 7266 * Newly added waived test system

21

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

82465QW (Contact your Medicare carrier for claims instructions.), 82947QW, 82950QW, 82951QW, 82952QW, 83036QW, 84478QW 82465QW(Contact your Medicare carrier for claims instructions.), 82947QW, 82950QW, 82951QW, 82952QW, 83718QW, 84478QW, 84450QW, 84460QW 82523QW 82565QW 82565QW, 84520QW

TEST NAME
Wako APOLOWAKO Analyzer (Whole Blood)

MANUFACTURER
Wako Chemicals USA, Inc.

USE
Measures total cholesterol, hemoglobin A1c, glucose, and triglycerides in whole blood

Abaxis Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood)}

Abaxis, Inc.

Measures cholesterol, HDL cholesterol, glucose, alanine aminotransferase, aspartate aminotransferase, and triglycerides in whole blood

Ostex International Osteomark NTX Point of Care Prescription Home Use Abbott i-STAT Crea Cartridge {Whole Blood} Abaxis Piccolo xpress Chemistry Analyzer (Kidney Check Panel){Whole Blood}

Ostex International Inc. i-Stat Corporation Abaxis, Inc.

Measures normalized cross-linked N-telopeptides of type 1 collagen in urine Quantitative measurement of creatinine in whole blood Quantitative measurement of creatinine and urea nitrogen in whole blood

This list includes updates from Change Request 7266 * Newly added waived test system

22

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

82040QW, 82150QW, 82247QW, 82310QW, 82565QW, 82947QW, 82950QW, 82951QW, 82952QW, 82977QW, 84075QW, 84155 QW, 84450QW, 84460QW, 84520QW, 84550QW

TEST NAME
1. Abaxis Piccolo Blood Chemistry Analyzer (General Chemistry 13 Panel){Whole Blood}

MANUFACTURER
Abaxis, Inc.

USE
Quantitative measurement of alanine aminotransferase, albumin, alkaline phosphatase, amylase, aspartate aminotransferase, calcium, creatinine, gamma glutamyltransferase, glucose, total bilirubin, total protein, urea nitrogen and uric acid in whole blood

2.

Abaxis Piccolo xpress Chemistry Analyzer (General Chemistry 13 Panel){Whole Blood} Abaxis Piccolo Blood Chemistry Analyzer (General Chemistry 6 Panel){Whole Blood}

Abaxis, Inc.

82565QW, 82947QW, 82950QW, 82951QW, 82952QW, 82977QW, 84450QW, 84460QW, 84520QW

1.

Abaxis, Inc.

Quantitative measurement of alanine aminotransferase, aspartate aminotransferase, creatinine, gamma glutamyltransferase, glucose and urea nitrogen in whole blood

2.

Abaxis Piccolo xpress Chemistry Analyzer (General Chemistry 6 Panel){Whole Blood}

Abaxis, Inc.

This list includes updates from Change Request 7266 * Newly added waived test system

23

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

82679QW (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.), 83002QW 82947QW, 82950QW, 82951QW, 82952QW

TEST NAME
Clearplan Easy Fertility Monitor (for luteinizing hormone and estrone 3 glucuronide)

MANUFACTURER
Unipath Limited

USE
Detection of luteinizing hormone and estrone 3 glucuronide in urine to identify the optimal time for conception

1.

HemoCue B-Glucose Photometer

HemoCue, Inc.

Measures glucose levels in whole blood

2.

HemoCue Glucose 201 Microcuvettes and Glucose 201 Analyzer Abbott i-STAT G Cartridge {Whole Blood}

HemoCue, Inc.

3. 82947QW, 82950QW, 82951QW, 82952QW, 84132QW, 84295QW, 85014QW 82985QW 82962, 82465QW(Contact your Medicare carrier for claims instructions.)

i-Stat Corporation i-Stat Corporation Measures glucose, potassium, sodium, and hematocrit in whole blood

Abbott i-STAT EC4+ Cartridge {Whole Blood}

LXN Fructosamine Test System Roche Diagnostics Accutrend Plus System {fingerstick whole blood}

LXN Corporation Roche Diagnostics

Used to evaluate diabetic control, reflecting diabetic control over a 2-3 week period (Not a useful test for screening diabetes mellitus) Monitoring of blood glucose levels and cholesterol

This list includes updates from Change Request 7266 * Newly added waived test system

24

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

82962, 82985QW

TEST NAME
1. LXN Duet Glucose Control Monitoring System LXN IN CHARGE Diabetes Control System Acon Laboratories, Inc. FSH Menopause Predictor Test Acon Laboratories, Inc. FSH One Step Menopause Test Device {Professional Use} Acon Laboratories, Inc. FSH One Step Menopause Test Strip {Professional Use} Applied Biotech, Inc. RU25 Plus FSH Menopause Test Biotechnostix, Inc. Rapid Response FSH One Step Menopause Test Device Genosis Fertell Female Fertility Test Genua Menopause Monitor Test Synova Healthcare MenocheckPro (Professional Use) Axis-Shield Afinion AS100 Analyzer Siemens Medical Diagnostics DCA Vantage Analyzer Siemens DCA 2000 Analyzer Siemens DCA 2000+ Analyzer

MANUFACTURER
LXN Corporation

USE
Monitoring of blood glucose levels and measures fructosamine, which is used to evaluate diabetic control, reflecting diabetic control over a 2-3 week period

2. 83001QW 1. 2.

LXN Corporation ACON Laboratories, Inc. ACON Laboratories, Inc. Detects follicle stimulating hormone in urine

3.

ACON Laboratories, Inc.

4. 5.

Applied Biotech, Inc. ACON Laboratories, Inc.

6. 7. 8.

Genosis, Inc. Genua 1944 Inc Applied Biotech, Inc.

83036QW

1. 2. 3. 4.

Axis-Sheild Poc As Siemens Healthcare Diagnostics, Inc. Siemens Healthcare Diagnostics, Inc. Siemens Healthcare Diagnostics, Inc

Measures the percent concentration of hemoglobin A1c in blood, which is used in monitoring the long-term care of people with diabetes

This list includes updates from Change Request 7266 * Newly added waived test system

25

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

83037QW

TEST NAME
1. Bayer A1CNow+ {For professional use} Bio-Rad Micromat II Hemoglobin A1c Prescription Home Use Test Cholestech GDX A1C Test (Prescription Home Use) Provalis Diagnostics Glycosal HbA1c Test Provalis Diagnostics In2it In-Office Analyzer (II) A1C Prescription Home Use Test System

MANUFACTURER
Bayer Corp.

USE
Measures the percent concentration of hemoglobin A1c in blood, which is used in monitoring the long-term care of people with diabetes using devices cleared by the FDA for home use

2. 3. 4. 5.

Bio-Rad Laboratories Cholestech Corporation Provalis Diagnostics Ltd. Provalis Diagnostics Ltd

83605QW 83655QW 83718QW 83718QW, 84478QW, 82947QW, 82950QW, 82951QW, 82952QW 83721QW 83880QW

KDK Corporation Lactate Pro System ESA Biosciences LeadCare II Blood Lead Testing System (whole blood) PTS Bioscanner (for OTC use) - for HDL cholesterol Polymer Technology Systems CardioChek PA Analyzer (PTS Panels Metabolic Chemistry Panel Test Strips)

KDK Corporation ESA Biosciences, Inc. Polymer Technology Systems, Inc. Polymer Technology Systems, Inc.

Quantitative measurement of lactate in whole blood Quantitative measurement of blood lead in whole blood Measures HDL cholesterol in whole blood Measures HDL cholesterol, triglycerides, and glucose in whole blood

Polymer Technology Systems Cardiochek PA Analyzer 1. 2. Biosite Triage Meter {Whole Blood} Biosite Triage Meter Plus {Whole Blood}

Polymer Technology Systems, Inc. Biosite Incorporated

Measures LDL cholesterol in whole blood Quantitative measurement of B-type natriuretic peptide (BNP)

83986QW

All qualitative color comparison pH testing - body fluids (other than blood)

Various

pH detection (acid-base balance) in body fluids such as semen, amniotic fluid, and gastric aspirates

This list includes updates from Change Request 7266 * Newly added waived test system

26

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

83986QW

TEST NAME
1. 2. 3. 4. 5. FemTek pHEM-ALERT Common Sense Ltd. Norma-Sense Vaginal Discharge pH Test Common Sense Ltd. VA-Sense Kit Common Sense Ltd. VS-Sense Test {qualitative} Lil Drug Store Products Inc. VagiScreen Vaginal Health Test

MANUFACTURER
FemTek, LLC Common Sense Ltd. Common Sense, Ltd. Common Sense, Ltd Lil Drug Store Products Inc. i-Stat Corporation

USE
Vaginal pH detection (acid-base balance)

84295QW, 84132QW, 85014QW 84443QW

Abbott i-STAT E3+ Cartridge {Whole Blood} 1. Aventir Biotech LLC, Forsure TSH Test {Whole Blood} BTNX, Inc Rapid Response Thyroid Stimulating Hormone (TSH) Test Cassette CLIAwaived Inc. Thyroid Test Rapid TSH Cassette {Whole Blood} ThyroTec, Inc. ThyroTest Whole Blood TSH Test Jant Pharmacal Accutest TSH {Whole Blood} Qualigen, Inc. FastChek TSH {Whole blood}

Measures potassium, sodium, and hematocrit in whole blood

Screening Devices Canada Inc. Screening Devices Canada Inc. Screening Devices Canada Inc. ThyroTes, Inc. Screening Devices Canada Inc. Screening Devices Canada Inc. Arkray, Inc. Cholestech Corporation Cholestech Corporation

Qualitative determination of human thyroid stimulating hormone (TSH) in whole blood, which is a rapid TSH assay for hypothyroidism screening in adults

2.

3.

4. 5. 6. 84520QW, 84450QW 84450QW 84460QW

Arkray SPOTCHEM EZ Chemistry Analyzer{whole blood} Cholestech LDX Aspartate Aminotransferase (AST)(SGOT) Cholestech LDX Alanine Aminotransferase (ALT) Test

Quantitative determination of blood urea nitrogen (BUN) and aspartate aminotransferase in whole blood Quantitative determination of aspartate aminotransferase in whole blood Quantitative determination of alanine aminotransferase in whole blood

This list includes updates from Change Request 7266 * Newly added waived test system

27

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

84703QW 85014QW

TEST NAME
Bayer Clinitek 50 Urine Chemistry Analyzer - for HCG, urine Wampole STAT-CRIT Hct

MANUFACTURER
Bayer Corp. Wampole Laboratories

USE
Diagnosis of pregnancy Screen for anemia

85018QW

1. 2. 3. 4.

Biosafe Laboratories, Inc., Anemiapro Self Screener HemoCue Donor Hemoglobin Checker System HemoCue HemoCue Hemoglobin System HemoCue Hemoglobin 201+ (Capillary, Venous, Arterial Whole Blood) HemoCue Hemoglobin 201+/HemoCue Hemoglobin Microcuvette System HemoCue Hb 301 System GDS Diagnostics HemoSite Meter for hemoglobin GDS Technology STAT-Site MHgb Test System

Biosafe Laboratories, Inc. HemoCue, Inc. HemoCue, Inc. HemoCue, Inc.

Measures hemoglobin level in whole blood

5.

HemoCue, Inc.

6. 85018QW(cont.) 7. 8. 85576QW 85610QW (Contact your Medicare carrier for claims instructions.)

HemoCue, Inc. GDS Technology, Inc. GDS Technology Accumetrics Inc. Avocet Medical, Inc. Qualitative assay to measure platelet aggregation Aid in screening for congenital deficiencies of Factors II, V, VII, X; screen for deficiency of prothrombin; evaluate heparin effect, coumadin or warfarin effect; screen for Vitamin K deficiency Measures hemoglobin level in whole blood

Accumetrics VerifyNow Aspirin Assay 1. AvoSure PT System (prescription home use)

2. 3. 4.

AvoSure Pro (professional use) CoaguChek PST for Prothrombin Time CoaguSense Self-Test Prothrombin Time/INR Monitoring System (Prescription Home Use)

Avocet Medical, Inc. Boehringer Mannheim Corporation Coagusense, Inc.

This list includes updates from Change Request 7266 * Newly added waived test system

28

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

85610QW(cont.) (Contact your Medicare carrier for claims instructions.)

TEST NAME
5. HemoSense INRatio System

MANUFACTURER
HemoSense, Inc.

USE
Aid in screening for congenital deficiencies of Factors II, V, VII, X; screen for deficiency of prothrombin; evaluate heparin effect, coumadin or warfarin effect; screen for Vitamin K deficiency

6. 7.

ITC Protime Microcoagulation System for Prothrombin Time International Technidyne ProTime Microcoagulation System (ProTime 3 Cuvette) Prescription Home Use International Technidyne ProTime Microcoagulation System (ProTime 3 Cuvette) Professional Use Lifescan Harmony INR Monitoring System -- Prescription Home Use and Professional Use

International Technidyne Corporation (ITC) International Technidyne Corporation International Technidyne Corporation Lifescan, Inc.

8.

9.

10. Roche/Boehringer Mannheim CoaguChek System for Professional Use 11. Roche Diagnostics Coaguchek PST 12. Roche Diagnostics Coagu Chek S Systems Test (for prothrombin time) 13. Roche Diagnostics CoaguChek XS 86294QW 1. Bion Diagnostic Sciences BTA stat Test (for home use) Matritech, Inc. NMP22 BladderCheck Test for Professional and Prescription Home Use Acceava Mono II {Whole Blood}

Roche Diagnostics/ Boehringer Mannheim Corporation Roche Diagnostics Roche Diagnostics

Roche Diagnostics Bion Diagnostic Sciences, Inc. Maritech, Inc. Immunoassay for the qualitative detection of bladder tumor associated antigen in urine of persons diagnosed with bladder cancer, and used as an aid in the management of bladder cancer patients

2.

86308QW

1.

Biosite Inc.

Qualitative screening test for the presence of heterophile antibodies in human whole blood, which is used as an aid in the diagnosis of infectious mononucleosis

This list includes updates from Change Request 7266 * Newly added waived test system

29

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

86308QW (cont.)

TEST NAME
2. Acceava Mono Cassette {For whole Blood} Acon Mononucleosis Rapid Test Device {Whole Blood} Acon Mononucleosis Rapid Test Strip {Whole Blood} Applied Biotech SureStep Mono Test (whole blood) BioStar Acceava Mono Test (whole blood) Cardinal Health SP Brand Rapid Test Mono {Whole Blood} Clearview MONO Whole Blood, K042272/A013 Clearview MONO Whole Blood, K042272/A016

MANUFACTURER
Princeton BioMeditech Corp. ACON Laboratories, Inc. ACON Laboratories, Inc. Applied Biotech, Inc. Wyntek Diagnostics, Inc. Cardinal Health Inverness Medical Professional Diagnostics Innovacon, Inc. Applied Biotech, Inc. Princeton BioMeditech Corp. Genzyme Diagnostics Wyntek Diagnostics, Inc. Beckman Coulter, Inc. Princeton BioMeditech Corp. ACON Laboratories, Inc.

USE
Qualitative screening test for the presence of heterophile antibodies in human whole blood, which is used as an aid in the diagnosis of infectious mononucleosis

3. 4. 5. 6. 7. 8. 9.

10. Clearview Mono-plus II 11. Consult Diagnostics Mononucleosis Cassette {Whole Blood}* 12. Genzyme Contrast Mono (whole blood) 13. Genzyme OSOM Mono Test 14. Icon Mono 15. Immuno Detector Mono {Whole Blood} 16. Instant Technologies iScreen Mononucleosis Rapid Test Device {Whole Blood} 17. Instant Technologies iScreen Mononucleosis Rapid Test Strip {Whole Blood} This list includes updates from Change Request 7266 * Newly added waived test system

ACON Laboratories, Inc.

30

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

86308QW (cont.)

TEST NAME
18. Jant Accutest Infectious Mononucleosis Test (whole blood) 19. Jant Pharmacal Accutest Value + Mononucleosis Rapid Test {Whole Blood} 20. LifeSign Status Mono {for whole blood} 21. LifeSign UniStep Mono Test (whole blood) 22. McKesson Medi-lab Performance Infectious Mononucleosis Test 23. Meridian ImmunoCard STAT Mono (for whole blood) 24. PerMaxim RediScreen Mononucleosis {Whole Blood} 25. Polymedco, Inc. Poly stat Mono 26. Poly Stat Mono Test {Whole Blood} 27. ProAdvantage by NDC Infectious Mononucleosis Test Device (Whole Blood Only) 28. Quidel Cards O.S. Mono (for whole blood) 29. Quidel QuickVue+ Infectious Mononucleosis (Whole Blood) 30. RAC Medical Clarity MONO Mononucleosis Rapid Test Device {Whole Blood} 31. Remel RIM A.R.C. Mono Test 32. Seradyn Color Q Mono (whole blood)

MANUFACTURER
Applied Biotech, Inc.

USE
Qualitative screening test for the presence of heterophile antibodies in human whole blood, which is used as an aid in the diagnosis of infectious mononucleosis

Innovacon, Inc.

Princeton BioMeditech Corp. Princeton BioMeditech Corp. Applied Biotech, Inc. Applied Biotech, Inc. ACON Laboratories, Inc. Applied Biotech, Inc. Innovacon, Inc. Biosite Inc.

Quidel Corporation Quidel Corporation ACON Laboratories, Inc.

Applied Biotech, Inc. Genzyme Diagnostics

This list includes updates from Change Request 7266 * Newly added waived test system

31

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

86308QW (cont.)

TEST NAME
33. Signify Mono Cassette {Whole Blood} 34. Signify Mono Whole Blood 35. Stanbio Rely Mono Rapid Test{Whole Blood} 36. Wampole Mono-Plus WB 37. Wyntek Diagnostics OSOM Mono Test (whole blood) 38. Wyntek Signify Mono Test

MANUFACTURER
Innovacon, Inc.

USE
Qualitative screening test for the presence of heterophile antibodies in human whole blood, which is used as an aid in the diagnosis of infectious mononucleosis

Inverness Medical Professional Diagnostics Innovacon, Inc. Wampole Laboratories Wyntek Diagnostics, Inc. Wyntek Diagnostics, Inc. SmithKline Diagnostics, Inc. Innovacon, Inc. Abbott Laboratories ACON Laboratories, Inc. Alfa Scientific Designs, Inc. Immunoassay for rapid, qualitative detection of IgG antibodies specific to Helicobacter pylori in whole blood

86318QW

1. 2. 3. 4. 5.

Abbott FlexPak HP Test for whole blood Abbott Laboratories Signify H. Pylori Cassette {Whole Blood} Abbott TestPack Plus H. pylori (for whole blood) Acon H. pylori Test Device Alfa Scientific Designs Instant View H. Pylori Whole Blood Rapid Test Applied Biotech SureStep H. pylori WB Test (whole blood) Beckman Coulter Primary Care Diagnostics Flexsure HP Test for IgG Antibodies to H. Pylori in Whole Blood Becton Dickinson Link 2 H. pylori Rapid Test (for whole blood) Cardinal Health SP Brand Rapid Test H. pylori (K990892)

6. 7.

Applied Biotech, Inc. Beckman Coulter, Inc.

8. 9.

Cortecs Diagnostics Limited Applied Biotech Inc.

This list includes updates from Change Request 7266 * Newly added waived test system

32

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

86318QW (cont.)

TEST NAME
10. Cardinal Health SP Brand Rapid Test H. pylori {Whole Blood}(K024350/A15) 11. Diagnostic Test Group Clarity H. pylori Rapid Test Device {Whole Blood} 12. EarlyDetect H. Pylori Whole Blood Rapid Test 13. Fisher Healthcare Sure-Vue H. pylori Test {Whole Blood} 14. Germaine Laboratories, Aimstep H. pylori {whole blood} 15. Henry Schein One Step+ H. Pylori Rapid Test Device (Whole Blood) 16. Immunostics Detector H. Pylori WB (H. pyloi Antibody Test) {Whole Blood} 17. Instant Technologies iScreen H.pylori Rapid Test Device 18. Inverness Medical Clearview H. pylori Test {whole blood} 19. JANT Pharmacal Corp. H. pylori WBTest 20. Inverness Medical Signify H. Pylori Whole Blood 21. LifeSign Status H.pylori (for whole blood) 22. Meridian BioScience ImmunoCard STAT! H.pylori Whole Blood Test 23. Polymedco, Inc. Poly stat H.pylori 24. Polymedco Poly Stat H. Pylori Test (Whole Blood)

MANUFACTURER
Innovacon, Inc.

USE
Immunoassay for rapid, qualitative detection of IgG antibodies specific to Helicobacter pylori in whole blood

Princeton BioMeditech Corp. Alpha Scientific Designs, Inc. Innovacon, Inc. ACON Laboratories, Inc. Innovacon, Inc. Princeton BioMeditech Corp. ACON Laboratories, Inc. Innovacon, Inc. Applied Biotech, Inc. Innovacon, Inc. Princeton BioMeditech Applied Biotech, Inc.

Applied Biotech, Inc. Innovacon, Inc.

This list includes updates from Change Request 7266 * Newly added waived test system

33

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

86318QW (cont.)

TEST NAME
25. Pro-Advantage by NDC H. pylori Device (Whole Blood) 26. QuickVue One-Step H. Pylori Test for Whole Blood 27. Quidel QuickVue One-Step H.pylori II Test. 28. Remel RIM A.R.C. H.pylori Test 29. SmithKline Diagnostics FlexSure HP Test for IgG Antibodies to H. pylori in Whole Blood 30. Trinity Uni-Gold H.pylori 31. Wampole Laboratories Clearview H. pylori II {finger stick or whole blood}

MANUFACTURER
Innovacon, Inc. Quidel Corporation Quidel Corporation Remel SmithKline Diagnostics, Inc.

USE
Immunoassay for rapid, qualitative detection of IgG antibodies specific to Helicobacter pylori in whole blood

Trinity Biotech Applied Biotech , Inc.

86618QW

Wampole PreVue B. burgdorferi Antibody Detection Assay 1. 2. OraSure Technologies OraQuick Rapid HIV-1 Antibody Test OraSure OraQuick Rapid HIV-1 Antibody Test fingerstick and venipuncture whole blood Trinity Biotech Uni-Gold Recombigen HIV Test (Fingerstick, Venipuncture Whole Blood) OraSure OraQuick Advance Rapid HIV-1/2 Antibody Test {oral fluid, fingerstick whole blood and venipuncture whole blood} Clearview Complete HIV 1/2 {Fingerstick Venipuncture, whole blood}

Wampole Laboratories

Qualitative detection of IgG/IgM antibodies to Borrelia burgdorferi (causative agent of Lyme disease) in whole blood Qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1)

86701QW

OraSure Technologies, Inc. OraSure Technologies, Inc.

3.

Trinity Biotech

86703QW

1.

OraSure Technologies, Inc.

Qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in oral fluid, fingerstick whole blood and venipuncture whole blood specimens

2.

Chembio Diagnostic Systems, Inc.

This list includes updates from Change Request 7266 * Newly added waived test system

34

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

87077QW

TEST NAME
1. 2. 3. 4. 5. 6. Ballard Medical Products CLOtest Delta West CLOtest GI Supply HP-FAST GI Supply, Div. Chek-Med Systems HP One Medical Instruments Corporation Pronto Dry H. pylori Serim Pyloritek Test Kit Stesans Maybe?Mom Mini Ovulation Microscope O2 Unlimited Donna Ovulation Tester

MANUFACTURER
Ballard Medical Products Delta West Tri-Med Specialties Mycoscience Labs, Inc. GI Supply Medical Instruments Corporation Serim LEC Associates O2 Unlimited Corp. Zymetx, Inc. Quidel Corporation

USE
Presumptive identification of Helicobacter pylori in gastric biopsy tissue, which has been shown to cause chronic active gastritis (ulcers)

87210QW

1. 2.

Detects ferning pattern in saliva which is used in the determination of ovulation (optimal for conception)

87449QW 87804QW

ZymeTx Zstatflu Test Quidel QuickVue Influenza Test

Qualitative determination of influenza types A and B from throat swab specimens that does not differentiate between types A and B Qualitative detection of influenza type A and type B antigens from nasal swab, nasal wash or nasal aspirate specimens that does not differentiate between influenza types A and B Qualitative detection of influenza type A and type B antigens from nasal swab, nasopharyngeal (NP) swab, nasal wash, nasal aspirate or nasal specimens that does differentiate between influenza types A and B

87804QW

1.

Quidel Quickvue Influenza A+B Test BinaxNow Influenza A & B Test, K092223 BinaxNOW Influenza A & B Test in nasopharyngeal (NP) swab and nasal wash/aspirate specimens, K041049 BinaxNOW Influenza A & B Test {Nasopharyngeal (Np) Swab and Nasal Wash/Aspirate Specimens}, K053126

Quidel Corporation

2. 3.

Binax, Inc Binax, Inc.

4.

Binax, Inc.

This list includes updates from Change Request 7266 * Newly added waived test system

35

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

87804QW (cont.)

TEST NAME
5. BinaxNOW Influenza A & B Test {Nasopharyngeal (Np) Swab and Nasal Wash/Aspirate Specimens and Nasal Specimens (NS)} Binax Now Flu A Test EarlyDetect Pro Influenza A Test SA Scientific SAS Influenza A Test Binax Now Flu B Test EarlyDetect Pro Influenza B Test SA Scientific SAS Influenza B Test Binax NOW RSV Test (K021687) Binax NOW RSV Test (K032166/A005) Fisher Scientific Sure-Vue RSV Test Integrated Biotechnology Quick Lab RSV Test Quidel Quick Vue RSV Test SA Scientific SAS RSV Alert

MANUFACTURER
Binax, Inc.

USE
Qualitative detection of influenza type A and type B antigens from nasal swab, nasopharyngeal (NP) swab, nasal wash, nasal aspirate or nasal specimens that does differentiate between influenza types A and B Qualitative detection of influenza type A antigen in nasopharyngeal specimens

87804QW

1. 2. 3.

Binax, Inc. SA Scientific, Inc SA Scientific, Inc. Binax, Inc. SA Scientific, Inc SA Scientific, Inc. Binax, Inc. Binax, Inc. SA Scientific, Inc. Integrated Biotechnology Corp. Quidel Corporation SA Scientific, Inc. Genzyme Corp. Rapid Pathogen Screening Wyntek Diagnostics, Inc.

87804QW

1. 2. 3.

Qualitative detection of influenza type B antigen in nasopharyngeal specimens

87807QW

1. 2. 3. 4. 5. 6.

Rapid immunoassay for the qualitative detection of respiratory syncytial virus antigen

87808QW 87809QW 87880QW

Genzyme OSOM Trichomonas Rapid Test Rapid Pathogen Screening RPS Adeno Detector 1. Abbott Signify Strep A Test (from throat swab only) Abbott Laboratories Signify Strep A Dipstick Acon Strep A Rapid Strip Test

Immunoassay for the qualitative detection of Trichomonas vaginalis antigens from vaginal swabs Immunochromatographic test for the qualitative detection of adenoviral antigens from eye fluid Rapidly detects GAS antigen from throat swabs and used as an aid in the diagnosis of GAS infection, which typically causes strep throat, tonsillitis, and scarlet fever

2. 3.

Innovacon, Inc. ACON Laboratories, Inc.

This list includes updates from Change Request 7266 * Newly added waived test system

36

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

87880QW (cont.)

TEST NAME
4. Acon Strep A Twist Rapid Test

MANUFACTURER
ACON Laboratories, Inc.

USE
Rapidly detects GAS antigen from throat swabs and used as an aid in the diagnosis of GAS infection, which typically causes strep throat, tonsillitis, and scarlet fever

5. 6. 7. 8. 9.

Applied Biotech SureStep Strep A (II) (direct from throat swab) Beckman Coulter ICON DS Strep A Test Beckman Coulter ICON SC Strep A Test Beckman Coulter Primary Care Diagnostics ICON DS Strep A Beckman Coulter Primary Care Diagnostics ICON FX Strep A Immunochemical Strep A Test

Applied Biotech, Inc. Princeton BioMeditech Corp. ACON Laboratories, Inc. ACON Laboratories, Inc. Beckman Coulter, Inc.

10. Becton Dickinson BD Chek Group A Strep A Test 11. Becton Dickinson LINK 2 Strep A Rapid Test (direct from throat swab) 12. Binax NOW Strep A Test 13. BioStar Acceava Strep A Test (direct specimen only) 14. Biotechnostix Rapid Response Strep A Rapid Test Device 15. Biotechnostix Rapid Response Strep A Rapid Test Strip 16. BTNX, Inc. Strep A Rapid Test* 17. Cardinal Health SP Brand Rapid Test Strep A Dipstick(K033855) 18. Cardinal Health SP Brand Rapid Test Strep A Dipstick (K010582/A028) This list includes updates from Change Request 7266 * Newly added waived test system

Innovacon, Inc. Applied Biotech, Inc.

Binax, Inc. Wyntek Diagnostics, Inc. Acon Laboratories Co. Acon Laboratories Co. Sa Scientific, Inc. Applied Biotech Inc. Innovacon, Inc.

37

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

87880QW (cont.)

TEST NAME
19. CLIA waived inc Rapid Strep A Test 20. DE Healthcare Products, TruView Strep A Test 21. DE Healthcare Products TruView Strep A Cassette Test 22. Diagnostic Test Group Clarity Strep A Rapid Test Strips 23. Fisher HealthCare Sure-Vue Strep A (direct from throat swab) 24. Genzyme Contrast Strep A (direct from throat swab) 25. Genzyme OSOM Strep A Ultra Test 25 Test Kit Size 26. Genzyme OSOM Ultra Strep A Test 27. Germaine Laboratories StrepAim Rapid Dipstick Test 28. Germaine Laboratories Strep AIM Tower 29. Henry Schein Inc, One Step+ Strep A Test 30. Henry Schein Inc, One Step+ Strep A Dipstick Test 31. Immunostics Detector Strep A Direct 32. Immunostics Immuno/Strep A Detector 33. Instant Technologies iStrep Strep A 34. Inverness Medical BioStar Acceava Strep A Test

MANUFACTURER
Sa Scientific, Inc.

USE
Rapidly detects GAS antigen from throat swabs and used as an aid in the diagnosis of GAS infection, which typically causes strep throat, tonsillitis, and scarlet fever

DE Healthcare Products ACON Laboratories, Inc. Princeton BioMeditech Corp. Applied Biotech, Inc. Genzyme Diagnostics Genzyme Corporation Genzyme General Germaine Laboratories, Inc. Germaine Laboratories, Inc. Henry Schein Henry Schein ACON Laboratories, Inc. ACON Laboratories, Inc. ACON Laboratories, Inc. Innovacon, Inc.

This list includes updates from Change Request 7266 * Newly added waived test system

38

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

87880QW (cont.)

TEST NAME
35. Inverness Medical BioStar Acceava Strep A Twist 36. Inverness Medical Signify Strep A Cassette (Inverness Medical Innovations) 37. Jant Pharmacal AccuStrip Strep A (II) (direct from throat swab) 38. Jant Pharmacal Accustrip Strep A Value+ Test Strip 39. Jant Pharmacal Accutest Integrated Strep A Rapid Test Device 40. Laboratory Supply Company (LSC) PEP Strep A Cassette Test 41. LSC PEP Strep A Dipstick Test 42. LifeSign LLC Status Strep A 43. Mainline Confirms Strep A Dots Test (direct from throat swab) 44. McKesson Medi-Lab Performance Strep A Test Dipstick 45. Meridian Diagnostics ImmunoCard STAT Strep A (direct from throat swab) 46. Moore Medical The Supply Experts Strep A Rapid Test Dipstick 47. PSS Consult Diagnostics Strep A Dipstick 48. PSS World Medical Select Diagnostics Strep A Dipstick 49. PSS World Medical Select Diagnostics Strep A Twist 50. Polymedco, Inc. Poly stat A (II)

MANUFACTURER
Innovacon, Inc.

USE
Rapidly detects GAS antigen from throat swabs and used as an aid in the diagnosis of GAS infection, which typically causes strep throat, tonsillitis, and scarlet fever

Innovacon, Inc.

Applied Biotech, Inc. Innovacon, Inc. Innovacon, Inc. Acon Laboratories Co. Acon Laboratories Co. Princeton BioMeditech Applied Biotech, Inc. Applied Biotech, Inc. Applied Biotech, Inc.

Innovacon, Inc. Innovacon, Inc. Innovacon, Inc. Innovacon, Inc. Applied Biotech, Inc.

This list includes updates from Change Request 7266 * Newly added waived test system

39

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

87880QW (cont.)

TEST NAME
51. Polymedco Poly Stat Strep A Liquid Test 52. QuickVue In-Line One-Step Strep A Test (K934484) 53. QuickVue Dipstick Strep A 54. Quidel QuickVue In-Line Strep A 55. Quidel QuickVue In-Line Strep A {direct from throat swab}(K934484/A013) 56. RAC Medical Clarity Strep A Rapid Test Strips 57. Remel RIM A.R.C. Strep A Test 58. SmithKline ICON Fx Strep A Test (from throat swab only) 59. Stanbio Laboratory E-Z Well Strep A Rapid Device Test 60. Stanbio QuStick Strep A 61. Wyntek Diagnostics OSOM Strep A Test 62. Wyntek OSOM Ultra Strep A Test

MANUFACTURER
Applied Biotech, Inc

USE
Rapidly detects GAS antigen from throat swabs and used as an aid in the diagnosis of GAS infection, which typically causes strep throat, tonsillitis, and scarlet fever

Quidel Corporation Quidel Corporation Quidel Corporation Quidel Corporation

Acon Laboratories Co. Applied Biotech, Inc. Binax, Inc. Acon Laboratories Co. Stanbio Laboratory Wyntek Diagnostics, Inc Wyntek Diagnostics, Inc.

87905QW

1.

Gryphus Diagnostics BVBlue

Gryphus Diagnositcs, LLC

Enzyme activity test for the detection of sialidase activity in vaginal fluid specimens, an enzyme produced by bacterial pathogens such as Gardnerella vaginais, Bacteroides spp., Prevotella spp., and Mobiluncus spp.

2. 87899QW

Genzyme Diagnostics OSOM BVBlue Test

Gryphus Diagnositcs, LLC Meridian Bioscience, Inc. Immunoassay for the qualitative detection of Helicobacter pylori antigens in stool specimens

Meridian Bioscience Immunocard STAT! HpSA {Stool}

This list includes updates from Change Request 7266 * Newly added waived test system

40

TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S)

89300QW(This test may not be covered in all instances. Contact your Medicare carrier for claims instructions)

TEST NAME
1. Embryotech Laboratories FertilMARQ Home Diagnostic Screening Test for Male Infertility

MANUFACTURER
Embryotech Laboratories, Inc.

USE
Screening test to measure sperm concentration

2. 89321QW

SpermCheck Vasectomy

Princeton BioMeditech Corp. Genosis Ltd.

Detects sperm in semen following a vasectomy Determines whether the concentration of motile sperm is above a cut-off level of 10 million motile sperm cells per ml

Fertell Male Fertility Test

This list includes updates from Change Request 7266 * Newly added waived test system

41