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) Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (JJE) (2) Igg, Antigen, Antiserum, Control (DEW) (2) Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (LFZ) (1) Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (LGD) (1)

Premarket Exempt

Yes No

Clear

VIDAS® - 03573026140427 Catalog Number :

Device Description : The VIDAS® system is a complete standalone immunodiagnostic system using VIDAS reagents.

Device Class : 2

Duns Number: 276816717

Premarket Exempt : No

Product Code : DEW

Prescription Use : Yes

Device Count : 1

mini VIDAS® - 03573026140441 Catalog Number :

Device Description : The mini VIDAS is a complete standalone immunodiagnostic system using VIDAS assay kits.

Device Class : 1

Duns Number: 276816717

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

API® NIN - 03573026141974 Catalog Number :

Device Description : NIN is a reagent associated to API® 20 Strep (20 600), API® Campy (20 800), rapi NIN is a reagent associated to API® 20 Strep (20 600), API® Campy (20 800), rapid ID 32 STREP (32 600)

Device Class : 1

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : Yes

Device Count : 1

API® PYZ - 03573026141981 Catalog Number :

Device Description : PYZ is a reagent associated to API® Coryne (20 900)

Device Class : 1

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : Yes

Device Count : 1

API® ZYM B - 03573026141998 Catalog Number :

Device Description : ZYM B is a reagent associated to API® Listeria (10 300), API® NH (10 400), API® ZYM B is a reagent associated to API® Listeria (10 300), API® NH (10 400), API® Staph (20 500), API® 20 Strep (20 600), API® Coryne (20 900), API® ZYM (25 200)

Device Class : 1

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : Yes

Device Count : 1

ZYM A - 03573026142001 Catalog Number :

Device Description : ZYM A is a reagent associated to API® Staph (20 500), API® 20 Strep (20 600), AP ZYM A is a reagent associated to API® Staph (20 500), API® 20 Strep (20 600), API® Coryne (20 900), API® ZYM (25 200)

Device Class : 1

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : Yes

Device Count : 1

VIDAS® - 03573026152482 Catalog Number :

Device Description : The VIDAS® system is a complete standalone immunodiagnostic system using VIDAS reagents.

Device Class : 2

Duns Number: 276816717

Premarket Exempt : No

Product Code : DEW

Prescription Use : Yes

Device Count : 1

mini VIDAS® - 03573026152499 Catalog Number :

Device Description : The mini VIDAS is a complete standalone immunodiagnostic system using VIDAS assay kits.

Device Class : 1

Duns Number: 276816717

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

VIDAS® TOXO IgM - 03573026156824 Catalog Number :

Device Description : TOXO IgM (TXM) assay is a qualitative IA intended for use on VIDAS family instr TOXO IgM (TXM) assay is a qualitative IA intended for use on VIDAS family instrument in the detection of anti - toxoplasma IgG concentration in human serum or plasma.

Device Class : 2

Duns Number: 276816717

Premarket Exempt : No

Product Code : LGD

Prescription Use : Yes

Device Count : 1

VIDAS® CMV IgG - 03573026156831 Catalog Number :

Device Description : VIDAS ® CMV IgG (CMVG) assay is a quantitative immunoassay intended for use on VIDAS ® CMV IgG (CMVG) assay is a quantitative immunoassay intended for use on VIDAS family instrument in the determination of CMV IgG concentration in human serum or plasma.

Device Class : 2

Duns Number: 276816717

Premarket Exempt : No

Product Code : LFZ

Prescription Use : Yes

Device Count : 1

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