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) (6) C-Reactive Protein, Antigen, Antiserum, And Control (DCK) (2) Calibrator, Primary (JIS) (2)

Premarket Exempt

No Yes

Clear

ABX LYSEBIO (1L) - 03610230004685 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : GGK

Prescription Use : No

Device Count : 1

ABX LYSEBIO (0.4L) - 03610230004692 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : GGK

Prescription Use : No

Device Count : 1

ABX ALPHALYSE (360mL) - 03610230004708 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : GGK

Prescription Use : No

Device Count : 1

MINILYSEBIO (1L) - 03610230004715 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : GGK

Prescription Use : No

Device Count : 1

MINILYSEBIO (0.4L) - 03610230004722 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : GGK

Prescription Use : No

Device Count : 1

WHITEDIFF (1L) - 03610230004746 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : GGK

Prescription Use : No

Device Count : 1

ABX CRP REA - 03610230004760 Catalog Number :

Device Class : 2

Duns Number: 273647420

Premarket Exempt : No

Product Code : DCK

Prescription Use : No

Device Count : 1

ABX CRP STD - 03610230004777 Catalog Number :

Device Class : 2

Duns Number: 273647420

Premarket Exempt : No

Product Code : JIS

Prescription Use : No

Device Count : 1

ABX PENTRA CRP CP - 03610230004791 Catalog Number :

Device Class : 2

Duns Number: 273647420

Premarket Exempt : No

Product Code : DCK

Prescription Use : No

Device Count : 1

ABX PENTRA CRP CAL - 03610230004821 Catalog Number :

Device Class : 2

Duns Number: 273647420

Premarket Exempt : No

Product Code : JIS

Prescription Use : No

Device Count : 1

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