Abbott Laboratories 100 Abbott Park Road Abbott Park, IL, 60064 April 6, 2016 Direccién General de Medicamentos, Insumos y drogas Ministry of Health — Peri To Whom It May Concer, We certify by way of this letter the following information related to the components for the below products: a Total Bilirubin ( List No 6145-21; reagent kit carton 2,750 test) Each kit has the following components: Reagent 1(RI) 10 cartridges X S3mL Reagent 2 (R2) 10 cartridges X 17mL Reagent | Ingredient Concentration RI Surfactants 451% HCL 8.204 g/L R2 2, 4-dichloroaniline O81 g/L HCl 5.563 g/L Sodium nitrate 0.345 g/L. Surfactant 1.96% Abbott [A Promise for Lite4. Albumin BCG ( List No 753 - 23; reagent kit carton 2,607 test) Each kit has the following components: Reagent 1(R1) 10 cartridges X 84 mL preservative Reagent | Ingredient Concentration RI Bromeresol green 0.27 mmol/L. TRIS 55 mmol/L Succinic acid 100 mmol/L Inactive ingredients: sodium azide asa | 0.1% e. Immunoglobulin A ( List No 9D98-21; reagent kit carton 373 test) Each kit has the following components: Reagent 1(R1) 4 cartridges X 20 mL, Reagent 2 (R2) 4 cartridges X 8 mL, Reagent | Ingredient Concentration RI Polyethylene glycol 30 g/L. TRIS 100 mmol/L. R2 Anti-human IgA goat serum, 50% TRIS 100 mmol/L Abbott A Promise for Life+. Urea Nitrogen (List No 7D75 - 21; reagent kit carton 1,500 test) Each kit has the following components: Reagent 1(R1) 5 cartridges X 10 mL, Reagent 2 (R2) 5 cartridges X 12 mL, preservative Reagent | Ingredient Concentration RI NADH 2.95 mmol/L Sodium Azide as preservative Inactive ingredient: Proclin as a preservative Inactive ingredient: sodium azide as <0.1% preservative R2 a-Ketoglutaric Acid 99.8 mmol/L Urease (jack bean) 23.5 KU/L GLD (beef liver) 63.5 KUIL Adenosine Diphosphate 7.6 mmol/L Inactive ingredient: sodium azide as <0.2% Date Diagnostics Division Regulatory Affairs Specialist Abbott AAPromise for Lite