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

Ldl & Vldl Precipitation, Hdl (LBR) (2) Diazo Colorimetry, Bilirubin (CIG) (2) Enzymatic, Carbon-Dioxide (KHS) (1) Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides (CDT) (1) Photometric Method, Iron (Non-Heme) (JIY) (1) Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) (JIQ) (1) Urease And Glutamic Dehydrogenase, Urea Nitrogen (CDQ) (1) Enzymatic Esterase--Oxidase, Cholesterol (CHH) (1)

Premarket Exempt

No Yes

Clear

ABX PENTRA CHOLESTEROL CP - 03610230004975 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : No

Product Code : CHH

Prescription Use : No

Device Count : 1

ABX PENTRA BILIRUBIN, DIRECT CP - 03610230004982 Catalog Number :

Device Class : 2

Duns Number: 273647420

Premarket Exempt : No

Product Code : CIG

Prescription Use : No

Device Count : 1

ABX PENTRA HDL DIRECT CP - 03610230004999 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : No

Product Code : LBR

Prescription Use : No

Device Count : 1

ABX PENTRA IRON CP - 03610230005002 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : No

Product Code : JIY

Prescription Use : No

Device Count : 1

ABX PENTRA LDL DIRECT CP - 03610230005019 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : No

Product Code : LBR

Prescription Use : No

Device Count : 1

ABX PENTRA BILIRUBIN, TOTAL CP - 03610230005026 Catalog Number :

Device Class : 2

Duns Number: 273647420

Premarket Exempt : No

Product Code : CIG

Prescription Use : No

Device Count : 1

ABX PENTRA TRIGLYCERIDES CP - 03610230005033 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : No

Product Code : CDT

Prescription Use : No

Device Count : 1

ABX PENTRA UREA CP - 03610230005040 Catalog Number :

Device Class : 2

Duns Number: 273647420

Premarket Exempt : No

Product Code : CDQ

Prescription Use : No

Device Count : 1

ABX PENTRA URINARY PROTEINS CP - 03610230005057 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : JIQ

Prescription Use : No

Device Count : 1

ABX PENTRA CO2 RTU - 03610230005071 Catalog Number :

Device Class : 2

Duns Number: 273647420

Premarket Exempt : No

Product Code : KHS

Prescription Use : No

Device Count : 1

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