ALFA WASSERMANN, INC.

Address:4 Henderson Dr,West Caldwell,NJ,07006,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Multi-Analyte Controls, All Kinds (Assayed) (JJY) (3) Enzymatic Esterase--Oxidase, Cholesterol (CHH) (2) Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides (CDT) (1) Acid, Uric, Uricase (Colorimetric) (KNK) (1) Photometric Method, Iron (Non-Heme) (JIY) (1) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1) System, Test, Low Density, Lipoprotein (MRR) (1)

Premarket Exempt

Clear

Alfa Wassermann - 00857969006402 Catalog Number : C1-5

Device Description : Level 2 Chemistry Control

Device Class : 1

Duns Number: 781990924

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

ACE - 00857969006419 Catalog Number : C2-85

Device Description : Urine Chemistry Controls

Device Class : 1

Duns Number: 781990924

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Alfa Wassermann - 00857969006426 Catalog Number : C2-86

Device Description : Hemoglobin A1c Controls

Device Class : 1

Duns Number: 781990924

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

Alfa Wassermann - 00857969006433 Catalog Number : C2-87

Device Description : Lipid Controls

Device Class : 1

Duns Number: 781990924

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

ACE - 00857969006440 Catalog Number : RX1010

Device Description : Cholesterol Reagent

Device Class : 1

Duns Number: 781990924

Premarket Exempt : No

Product Code : CHH

Prescription Use : No

Device Count : 1

ACE - 00857969006457 Catalog Number : RX1023

Device Description : Triglycerides Reagent

Device Class : 1

Duns Number: 781990924

Premarket Exempt : No

Product Code : CDT

Prescription Use : No

Device Count : 1

ACE - 00857969006464 Catalog Number : RX1025

Device Description : Uric Acid Reagent

Device Class : 1

Duns Number: 781990924

Premarket Exempt : No

Product Code : KNK

Prescription Use : No

Device Count : 1

ACE - 00857969006471 Catalog Number : RX1026

Device Description : LDL-C Reagent

Device Class : 1

Duns Number: 781990924

Premarket Exempt : No

Product Code : MRR

Prescription Use : No

Device Count : 1

ACE - 00857969006488 Catalog Number : SA1010

Device Description : Cholesterol Reagent

Device Class : 1

Duns Number: 781990924

Premarket Exempt : No

Product Code : CHH

Prescription Use : No

Device Count : 1

ACE - 00857969006495 Catalog Number : SA1017

Device Description : Total Iron Reagent

Device Class : 1

Duns Number: 781990924

Premarket Exempt : No

Product Code : JIY

Prescription Use : No

Device Count : 1

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