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

Nadh Oxidation/Nad Reduction, Ast/Sgot (CIT) (2) Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (JJE) (1) Assay, Glycosylated Hemoglobin (LCP) (1) Calibrator, Primary (JIS) (1) Nadh Oxidation/Nad Reduction, Alt/Sgpt (CKA) (1)

Premarket Exempt

Clear

Alfa Wassermann - 00857969006600 Catalog Number : S2-87

Device Description : Hemoglobin A1c Calibrators

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : JIS

Prescription Use : No

Device Count : 1

ACE - 00857969006617 Catalog Number : SA1050

Device Description : Hemoglobin A1c Reagent

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

ACE - 00857969006624 Catalog Number : SA1020

Device Description : NORMAL SALINE DILUENT

Device Class :

Duns Number: 781990924

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ACE - 00857969006631 Catalog Number : SA1021

Device Description : SYSTEM DILUENT

Device Class :

Duns Number: 781990924

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ACE - 00857969006648 Catalog Number : SA1027

Device Description : ISE WASH

Device Class :

Duns Number: 781990924

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ACE - 00857969006655 Catalog Number : SA1028

Device Description : ISE CLEANING AND SODIUM ELECTRODE CONDITIONER

Device Class :

Duns Number: 781990924

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ACE - 00857969006662 Catalog Number : SA1052

Device Description : ALT Reagent

Device Class : 1

Duns Number: 781990924

Premarket Exempt : No

Product Code : CKA

Prescription Use : No

Device Count : 1

ACE - 00857969006679 Catalog Number : SA1053

Device Description : AST Reagent

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : CIT

Prescription Use : No

Device Count : 1

ACE - 00857969006686 Catalog Number : RX1053

Device Description : AST Reagent

Device Class : 2

Duns Number: 781990924

Premarket Exempt : No

Product Code : CIT

Prescription Use : No

Device Count : 1

ACE Alera® - 00857969006693 Catalog Number : 402900-1

Device Description : ACE Alera Clinical Chemistry System with ISE

Device Class : 1

Duns Number: 781990924

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

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