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) Calibrator, Secondary (JIT) (2) Diluent, Blood Cell (GIF) (1) Phosphomolybdate (Colorimetric), Inorganic Phosphorus (CEO) (1) Photometric Method, Magnesium (JGJ) (1) Bromcresol Green Dye-Binding, Albumin (CIX) (1) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1) Calibrator, Multi-Analyte Mixture (JIX) (1)

Premarket Exempt

No Yes

Clear

ABX PENTRA MAGNESIUM RTU - 03610230005088 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : No

Product Code : JGJ

Prescription Use : No

Device Count : 1

ABX PENTRA HDL CAL - 03610230005095 Catalog Number :

Device Class : 2

Duns Number: 273647420

Premarket Exempt : No

Product Code : JIT

Prescription Use : No

Device Count : 1

ABX PENTRA CO2 CAL - 03610230005101 Catalog Number :

Device Class : 2

Duns Number: 273647420

Premarket Exempt : No

Product Code : JIT

Prescription Use : No

Device Count : 1

ABX PENTRA CO2 CONTROL - 03610230005118 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

ABX PENTRA MULTICAL - 03610230005125 Catalog Number :

Device Class : 2

Duns Number: 273647420

Premarket Exempt : No

Product Code : JIX

Prescription Use : No

Device Count : 1

ABX PENTRA N CONTROL - 03610230005132 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

ABX PENTRA P CONTROL - 03610230005149 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

ABX PENTRA SAMPLE DILUENT CP - 03610230005170 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : GIF

Prescription Use : No

Device Count : 1

ABX PENTRA ALBUMIN CP - 03610230005187 Catalog Number :

Device Class : 2

Duns Number: 273647420

Premarket Exempt : No

Product Code : CIX

Prescription Use : No

Device Count : 1

ABX PENTRA PHOSPHORUS CP - 03610230005194 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : No

Product Code : CEO

Prescription Use : No

Device Count : 1

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