HORIBA ABX SAS

Address:PARC EUROMEDECINE,MONTPELLIER Herault,FR

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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

Multi-Analyte Controls, All Kinds (Assayed) (JJY) (2) Catalytic Methods, Amylase (JFJ) (1) Kinetic Method, Gamma-Glutamyl Transpeptidase (JQB) (1) Lipase-Esterase, Enzymatic, Photometric, Lipase (CHI) (1) Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes (CGS) (1) Nadh Oxidation/Nad Reduction, Alt/Sgpt (CKA) (1) Nadh Oxidation/Nad Reduction, Ast/Sgot (CIT) (1) Calibrator, Secondary (JIT) (1) Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (CJE) (1)

Premarket Exempt

No Yes

Clear

ABX Pentra RF Cal - 03610230004845 Catalog Number :

Device Class : 2

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : Yes

Device Count : 1

ABX PENTRA IMMUNO I CONTROL L/H - 03610230004876 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

ABX PENTRA IMMUNO II CONTROL L/H - 03610230004883 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

ABX PENTRA ALP CP - 03610230004890 Catalog Number :

Device Class : 2

Duns Number: 273647420

Premarket Exempt : No

Product Code : CJE

Prescription Use : No

Device Count : 1

ABX PENTRA ALT CP - 03610230004906 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : CKA

Prescription Use : No

Device Count : 1

ABX PENTRA AMYLASE CP - 03610230004913 Catalog Number :

Device Class : 2

Duns Number: 273647420

Premarket Exempt : No

Product Code : JFJ

Prescription Use : No

Device Count : 1

ABX PENTRA AST CP - 03610230004920 Catalog Number :

Device Class : 2

Duns Number: 273647420

Premarket Exempt : No

Product Code : CIT

Prescription Use : No

Device Count : 1

ABX PENTRA GGT CP - 03610230004937 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : JQB

Prescription Use : No

Device Count : 1

ABX PENTRA LIPASE CP - 03610230004944 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : CHI

Prescription Use : No

Device Count : 1

ABX PENTRA CK NAC CP - 03610230004951 Catalog Number :

Device Class : 2

Duns Number: 273647420

Premarket Exempt : No

Product Code : CGS

Prescription Use : No

Device Count : 1

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