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

Products, Red-Cell Lysing Products (GGK) (5) General Purpose Reagent (PPM) (4) C-Reactive Protein, Antigen, Antiserum, And Control (DCK) (1)

Premarket Exempt

No Yes

Clear

ABX BASOLYSE - 03610230004425 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : GGK

Prescription Use : No

Device Count : 1

ABX EOSINOFIX (1L) - 03610230004432 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : GGK

Prescription Use : No

Device Count : 1

ABX LEUCODIFF 1L - 03610230004456 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : GGK

Prescription Use : No

Device Count : 1

ABX MINOCLAIR (0.5L) - 03610230004463 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

ABX MINICLEAN (1L) - 03610230004470 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

ABX CRP 100 - 03610230004487 Catalog Number :

Device Class : 2

Duns Number: 273647420

Premarket Exempt : No

Product Code : DCK

Prescription Use : No

Device Count : 1

ABX MINIPACK LMG - 03610230004494 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

MINIPACK AD60 (x4) - 03610230004524 Catalog Number :

Device Class :

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 4

ABX MINILYSE (1L) - 03610230004548 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : GGK

Prescription Use : No

Device Count : 1

ABX MINILYSE LMG (1L) - 03610230004555 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : GGK

Prescription Use : No

Device Count : 1

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