BIOMERIEUX SA

Address:PARC TECHNOLOGIQUE DELTA SUD,VERNIOLLE Ariege,FR

Want to know more about this Organization? Request more information now!

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

DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION (JTO) (6) CULTURE MEDIA, SELECTIVE BROTH (JSD) (1) Enzyme Linked Immunoabsorbent Assay, Rubella (LFX) (1) Medical device data system (OUG) (1) Multi-analyte controls unassayed (OHQ) (1)

Premarket Exempt

No Yes

Clear

API® BCP - 03573026099855 Catalog Number :

Device Description : BCP is a reagent associated to API 20 A® (20 300) & rapid ID 32 E (32 700)

Device Class : 1

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : Yes

Device Count : 1

API® EHR - 03573026099862 Catalog Number :

Device Description : EHR is a reagent associated to API 20 A® (20 300)

Device Class : 1

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : Yes

Device Count : 1

API® JAMES - 03573026099893 Catalog Number :

Device Description : JAMES is a reagent associated to API® NH, API 20 ETM, API® 10 S, RapiD 20 ETM, A JAMES is a reagent associated to API® NH, API 20 ETM, API® 10 S, RapiD 20 ETM, API® 20 NE, RAPIDEC® ur, ID 32 E), rapid ID 32 A, rapid ID 32 E

Device Class : 1

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : Yes

Device Count : 1

API® FB - 03573026099923 Catalog Number :

Device Description : FB is a reagent associated to API® Campy (20 800), ID 32 STAPH (32 500), rapid I FB is a reagent associated to API® Campy (20 800), ID 32 STAPH (32 500), rapid ID 32 A (32 300), 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® VPA VPB - 03573026099947 Catalog Number :

Device Description : VPA VPB is a reagent associated to ID 32 STAPH (32 500) & 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® McFarland Standard - 03573026100087 Catalog Number :

Device Description : McFarland Standard is a series of standards of different opacity, allowing the e McFarland Standard is a series of standards of different opacity, allowing the estimation of the density of bacterial suspensions.

Device Class : 1

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : Yes

Device Count : 1

TODD H-T - 03573026118723 Catalog Number :

Device Description : selective enrichment broth for the detection of group B streptococci in pregnant women.

Device Class :

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : JSD

Prescription Use : Yes

Device Count : 20

VIDAS® QCV - 03573026121631 Catalog Number :

Device Description : Automated test for use on the VIDAS® system to detect abnormal operation of the Automated test for use on the VIDAS® system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical systems.

Device Class : 1

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

APIWEB™ - 03573026133542 Catalog Number :

Device Description : APIWEB is a web based application for interpretation of biochemical/digital prof APIWEB is a web based application for interpretation of biochemical/digital profiles for identification of microorganisms obtained from ID 32, rapid ID 32, and API strips.

Device Class : 1

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : Yes

Device Count : 1

VIDAS® RUB IgG - 03573026138585 Catalog Number :

Device Description : VIDAS ® RUB IgG (RBG) assay is a quantitative IA intended for use on VIDAS fami VIDAS ® RUB IgG (RBG) assay is a quantitative IA intended for use on VIDAS family instrument in the determination of IgG antibodies to rubella virus in human serum.

Device Class : 2

Duns Number: 276816717

Premarket Exempt : No

Product Code : LFX

Prescription Use : Yes

Device Count : 1

Previous 1 2 3 4 5 … 31 Next