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

Diluent, Blood Cell (GIF) (4) General Purpose Reagent (PPM) (2) Products, Red-Cell Lysing Products (GGK) (2) Stains, Chemical Solution (LED) (2)

Premarket Exempt

No Yes

Clear

ABX MINIDIL LMG (10L) - 03610230004562 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : GIF

Prescription Use : No

Device Count : 1

ABX MINIDIL LMG (20L) - 03610230004579 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : GIF

Prescription Use : No

Device Count : 1

ABX DILUENT (10L) - 03610230004586 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : GIF

Prescription Use : No

Device Count : 1

ABX DILUENT (20L) - 03610230004609 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : GIF

Prescription Use : No

Device Count : 1

ABX CLEANER (1L) - 03610230004616 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

ABX CLEANER (0.5L) - 03610230004623 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

ABX RETIX (0.5L) - 03610230004630 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : LED

Prescription Use : No

Device Count : 1

ABX FLUOCYTE (0.5L) - 03610230004647 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : LED

Prescription Use : No

Device Count : 1

ABX BASOLYSE II - 03610230004654 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : GGK

Prescription Use : No

Device Count : 1

ABX ALPHALYSE (0.4L) - 03610230004661 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : GGK

Prescription Use : No

Device Count : 1

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