BIOMERIEUX SA

Address:PARC TECHNOLOGIQUE DELTA SUD,VERNIOLLE Ariege,FR

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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

DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION (JTO) (4) ENZYME LINKED IMMUNOABSORBENT ASSAY, MUMPS VIRUS (LJY) (1) CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL (JSG) (1) Enzyme linked immunoabsorbent assay, rubeola IgG (LJB) (1) KIT, IDENTIFICATION, ENTEROBACTERIACEAE (JSS) (1) KIT, IDENTIFICATION, YEAST (JXB) (1) Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster (LFY) (1)

Premarket Exempt

No Yes

Clear

VIDAS® Varicella-Zoster IgG - 03573026064518 Catalog Number :

Device Description : VIDAS VARICEL. ZOSTER IGG assay is a quantitative IA intended for use on VIDAS

Device Class : 2

Duns Number: 276816717

Premarket Exempt : No

Product Code : LFY

Prescription Use : Yes

Device Count : 1

VIDAS® Mumps IgG - 03573026064525 Catalog Number :

Device Description : VIDAS Mumps IgG (MPG) is qualitative test for use on s VIDAS family instruments

Device Class : 1

Duns Number: 276816717

Premarket Exempt : No

Product Code : LJY

Prescription Use : Yes

Device Count : 1

VIDAS® Measles IgG - 03573026064532 Catalog Number :

Device Description : VIDAS Measles IgG (MSG) assay is a quantitative IA intended for use on VIDAS fam

Device Class : 1

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : LJB

Prescription Use : Yes

Device Count : 1

ID 32 C - 03573026066383 Catalog Number :

Device Description : ID 32 C is a standardized system for the identification of yeasts, which uses 32

Device Class : 1

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : JXB

Prescription Use : Yes

Device Count : 1

Trypcase Soy Broth - 03573026073589 Catalog Number :

Device Description : Trypcase Soy broth is a culture medium for the growth of most non-fastidious mic

Device Class :

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : JSG

Prescription Use : Yes

Device Count : 20

ID indole TDA - 03573026092443 Catalog Number :

Device Description : Detection in enterobacteria of indole production and the presence of a tryptopha

Device Class : 1

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : JSS

Prescription Use : Yes

Device Count : 1

MINERAL OIL - 03573026099442 Catalog Number :

Device Description : Reagent associated to all API references except API LISTERIA (10 300) 1 API ZYM

Device Class : 1

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : Yes

Device Count : 1

API® TDA - 03573026099596 Catalog Number :

Device Description : TDA is a reagent associated to API 20 E (20 100/20 160), API® 10 S (10 100)

Device Class : 1

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : Yes

Device Count : 1

API® VP1 VP2 - 03573026099626 Catalog Number :

Device Description : VP1 VP2 are reagents associated to API 20 E™ (20 100/20 160), RapiD 20 E™ (20 70

Device Class : 1

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : Yes

Device Count : 1

API® NIT1 NIT2 - 03573026099671 Catalog Number :

Device Description : Reagents associated to API 20 E™ (20 100/20 160), API® 10 S (10 100), API® 20 NE

Device Class : 1

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : Yes

Device Count : 1

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