ALFA WASSERMANN, INC.

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

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Filters

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

Calibrator, Primary (JIS) (2) Biuret (Colorimetric), Total Protein (CEK) (1) Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine (KLI) (1) Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase (CFJ) (1) Nadh Oxidation/Nad Reduction, Ast/Sgot (CIT) (1) Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (CJE) (1) Saccharogenic, Amylase (CIJ) (1) Assay, Glycosylated Hemoglobin (LCP) (1) Urease, Photometric, Urea Nitrogen (CDN) (1)

Premarket Exempt

Clear

Alfa Wassermann - 00857969006204 Catalog Number : S2-86

Device Description : Hemoglobin A1c Calibrators

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : JIS

Prescription Use : No

Device Count : 1

ACE - 00857969006211 Catalog Number : S3-4

Device Description : T4 Calibrators

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : JIS

Prescription Use : No

Device Count : 1

ACE - 00857969006228 Catalog Number : SA1004

Device Description : Amylase Reagent

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : CIJ

Prescription Use : No

Device Count : 1

ACE - 00857969006235 Catalog Number : SA1022

Device Description : Total Protein Reagent

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : CEK

Prescription Use : No

Device Count : 1

ACE - 00857969006242 Catalog Number : SA1044

Device Description : Hemoglobin A1c Reagent

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : LCP

Prescription Use : No

Device Count : 1

ACE - 00857969006259 Catalog Number : SA1047

Device Description : AST Reagent

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : CIT

Prescription Use : No

Device Count : 1

ACE - 00857969006266 Catalog Number : SA2024

Device Description : BUN / UREA Reagent

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : CDN

Prescription Use : No

Device Count : 1

ACE - 00857969006273 Catalog Number : SA3007

Device Description : T4 Reagent

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : KLI

Prescription Use : No

Device Count : 1

ACE - 00857969006280 Catalog Number : SA3018

Device Description : LDH-L Reagent

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : CFJ

Prescription Use : No

Device Count : 1

ACE - 00857969006297 Catalog Number : RX2002

Device Description : Alkaline Phosphatase Reagent

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : CJE

Prescription Use : No

Device Count : 1

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