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) (5) KIT, ANAEROBIC IDENTIFICATION (JSP) (1) KIT, IDENTIFICATION, ENTEROBACTERIACEAE (JSS) (1) KIT, IDENTIFICATION, YEAST (JXB) (1) KIT, SCREENING, STAPHYLOCOCCUS AUREUS (JWX) (1) Manual antimicrobial susceptibility test systems (JWY) (1)

Premarket Exempt

No Yes

Clear

API® Listeria - 03573026035587 Catalog Number :

Device Description : API® Listeria is a standardized system for the identification of Listeria, which API® Listeria is a standardized system for the identification of Listeria, which uses miniaturized tests, as well as a database

Device Class : 1

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : Yes

Device Count : 1

API® NH - 03573026035600 Catalog Number :

Device Description : API® NH is for ID of Neisseria, Haemophilus (and related genera) and Moraxella c API® NH is for ID of Neisseria, Haemophilus (and related genera) and Moraxella catarrhalis (Branhamella catarrhalis).

Device Class : 1

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : Yes

Device Count : 1

API® 20 NE - 03573026047702 Catalog Number :

Device Description : API 20 NE is a standardized system for the ID of non-fastidious, non-enteric Gra API 20 NE is a standardized system for the ID of non-fastidious, non-enteric Gram-negative rods (e.g. Pseudomonas, Acinetobacter, Flavobacterium, Moraxella, etc.)

Device Class : 1

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : JSS

Prescription Use : Yes

Device Count : 1

API® 20 C AUX - 03573026048082 Catalog Number :

Device Description : API 20 C AUX is a system for the precise identification of the most frequently e API 20 C AUX is a system for the precise identification of the most frequently encountered yeasts.

Device Class : 1

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : JXB

Prescription Use : Yes

Device Count : 1

API® 20 A - 03573026048150 Catalog Number :

Device Description : The API 20 A system enables 21 tests to be carried out for ID of anaerobes. Othe The API 20 A system enables 21 tests to be carried out for ID of anaerobes. Other tests such as colonial and microscopic morphology, Gram stain, etc. to confirm or complete ID

Device Class : 1

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : JSP

Prescription Use : Yes

Device Count : 1

API® Staph - 03573026048259 Catalog Number :

Device Description : API® Staph is a standardized system for the identification of the genera Staphyl API® Staph is a standardized system for the identification of the genera Staphylococcus, Micrococcus and Kocuria

Device Class : 1

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : JWX

Prescription Use : Yes

Device Count : 1

API® STREP - 03573026048440 Catalog Number :

Device Description : API 20 Strep combines 20 biochemical tests to enable group or species ID of most API 20 Strep combines 20 biochemical tests to enable group or species ID of most streptococci and enterococci

Device Class : 1

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : Yes

Device Count : 1

API® Campy - 03573026048792 Catalog Number :

Device Description : API Campy is a standardized system for the identification of Campylobacter.

Device Class : 1

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : Yes

Device Count : 1

API® Coryne - 03573026049133 Catalog Number :

Device Description : API Coryne is a standardized system for the identification of coryneform bacteri API Coryne is a standardized system for the identification of coryneform bacteria in 24 hours

Device Class : 1

Duns Number: 276816717

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : Yes

Device Count : 1

Etest® IMIPENEM RELEBACTAM - 03573026049966 Catalog Number :

Device Description : Etest is a quantitative technique for determining susceptibility of clinically s Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination.

Device Class : 2

Duns Number: 276816717

Premarket Exempt : No

Product Code : JWY

Prescription Use : Yes

Device Count : 1

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