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) (2) Azo Dye, Calcium (CJY) (1) Bromcresol Green Dye-Binding, Albumin (CIX) (1) Enzymatic, Carbon-Dioxide (KHS) (1) Ferritin, Antigen, Antiserum, Control (DBF) (1) Hexokinase, Glucose (CFR) (1) Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes (CGS) (1) Alkaline Picrate, Colorimetry, Creatinine (CGX) (1) Nadh Oxidation/Nad Reduction, Ast/Sgot (CIT) (1)

Premarket Exempt

Clear

ACE - 00857969006105 Catalog Number : SA1009

Device Description : Calcium-Arsenazo Reagent

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : CJY

Prescription Use : No

Device Count : 1

ACE - 00857969006112 Catalog Number : SA1012

Device Description : Creatinine Reagent

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : CGX

Prescription Use : No

Device Count : 1

ACE - 00857969006129 Catalog Number : SA1014

Device Description : Glucose Reagent

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : CFR

Prescription Use : No

Device Count : 1

ACE - 00857969006136 Catalog Number : SA2001

Device Description : Albumin Reagent

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : CIX

Prescription Use : No

Device Count : 1

ACE - 00857969006143 Catalog Number : SA2011

Device Description : CK Reagent

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : CGS

Prescription Use : No

Device Count : 1

ACE - 00857969006150 Catalog Number : SA2039

Device Description : Carbon Dioxide Reagent

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : KHS

Prescription Use : No

Device Count : 1

ACE - 00857969006167 Catalog Number : ACI-35

Device Description : Ferritin Application Kit

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : DBF

Prescription Use : No

Device Count : 1

ACE - 00857969006174 Catalog Number : RX1047

Device Description : AST Reagent

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : CIT

Prescription Use : No

Device Count : 1

Alfa Wassermann - 00857969006181 Catalog Number : S1-33

Device Description : GemCal Reference Serum

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : JIX

Prescription Use : No

Device Count : 1

Alfa Wassermann - 00857969006198 Catalog Number : S2-85

Device Description : Urine Standard

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : JIX

Prescription Use : No

Device Count : 1

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