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, Multi-Analyte Mixture (JIX) (1) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (1) Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (CJE) (1)

Premarket Exempt

Clear

ACE - 00857969006303 Catalog Number : SA2002

Device Description : Alkaline Phosphatase Reagent

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : CJE

Prescription Use : No

Device Count : 1

Alfa Wassermann - 00857969006310 Catalog Number : E1-2

Device Description : CAL B

Device Class :

Duns Number: 781990924

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Alfa Wassermann - 00857969006327 Catalog Number : E1-3

Device Description : REFERENCE ELECTRODE SOLUTION

Device Class :

Duns Number: 781990924

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ACE - 00857969006334 Catalog Number : E1-5

Device Description : Starlyte Cleaning Solution

Device Class :

Duns Number: 781990924

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ACE - 00857969006341 Catalog Number : E1-6

Device Description : Starlyte Sodium Electrode Conditioner

Device Class :

Duns Number: 781990924

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ACE - 00857969006358 Catalog Number : E1-7

Device Description : Urine Diluent

Device Class :

Duns Number: 781990924

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ACE - 00857969006365 Catalog Number : E1-8

Device Description : Starlyte III Fluid Pack

Device Class :

Duns Number: 781990924

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Alfa Wassermann - 00857969006372 Catalog Number : E1-9

Device Description : STARLYTE V Fluid Pack

Device Class :

Duns Number: 781990924

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Alfa Wassermann - 00857969006389 Catalog Number : SA1029

Device Description : CAL A

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : JIX

Prescription Use : No

Device Count : 1

Alfa Wassermann - 00857969006396 Catalog Number :

Device Description : Level 1 Chemistry Control

Device Class : 1

Duns Number: 781990924

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

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