ALFA WASSERMANN, INC.

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

Diazo Colorimetry, Bilirubin (CIG) (2) Calibrator, Primary (JIS) (1) Calibrator, Secondary (JIT) (1) Electrode, Ion Specific, Potassium (CEM) (1) Electrode, Ion Specific, Sodium (JGS) (1) Electrode, Ion-Specific, Chloride (CGZ) (1) Ferrozine (Colorimetric) Iron Binding Capacity (JMO) (1) Alkaline Picrate, Colorimetry, Creatinine (CGX) (1) Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes (CGS) (1)

Premarket Exempt

No

Clear

ACE - 00857969006006 Catalog Number : S2-76

Device Description : KIT, DIRECT TIBC CALIBRATOR

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : JIT

Prescription Use : No

Device Count : 1

ACE - 00857969006013 Catalog Number : S2-71

Device Description : LDL Cholesterol (LDL-C) Calibrator

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : JIS

Prescription Use : No

Device Count : 1

ACE - 00857969006020 Catalog Number : ACI-32

Device Description : Direct Total Iron-Binding Capacity (TIBC) Reagent

Device Class : 1

Duns Number: 781990924

Premarket Exempt : No

Product Code : JMO

Prescription Use : No

Device Count : 1

Alfa Wassermann - 00857969006037 Catalog Number : 903393

Device Description : Electrode, Sodium

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : JGS

Prescription Use : No

Device Count : 1

Alfa Wassermann - 00857969006044 Catalog Number : 903394

Device Description : Electrode, Potassium

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : CEM

Prescription Use : No

Device Count : 1

Alfa Wassermann - 00857969006051 Catalog Number : 906178

Device Description : Electrode, Chloride

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : CGZ

Prescription Use : No

Device Count : 1

ACE - 00857969006068 Catalog Number : RX1012

Device Description : Creatinine Reagent

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : CGX

Prescription Use : No

Device Count : 1

ACE - 00857969006075 Catalog Number : RX2011

Device Description : CK Reagent

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : CGS

Prescription Use : No

Device Count : 1

ACE - 00857969006082 Catalog Number : SA1007

Device Description : Direct Bilirubin Reagent

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : CIG

Prescription Use : No

Device Count : 1

ACE - 00857969006099 Catalog Number : SA1008

Device Description : Total Bilirubin Reagent

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : CIG

Prescription Use : No

Device Count : 1

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