BIOMERIEUX , INC.

Address:100 RODOLPHE ST,DURHAM,NC,27712,US

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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

System, blood culturing (MDB) (3) System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (LON) (2) KIT, IDENTIFICATION, YEAST (JXB) (1) KIT, ANAEROBIC IDENTIFICATION (JSP) (1) System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates (PEX) (1) Susceptibility Test Plate, Antifungal (NGZ) (1) KIT, FASTIDIOUS ORGANISMS (JST) (1)

Premarket Exempt

No Yes

Clear

DensiCHEK™ plus - 03573026222239 Catalog Number :

Device Description : The DensiCHEK™ Plus instrument is designed for use with the VITEK®2 System to me The DensiCHEK™ Plus instrument is designed for use with the VITEK®2 System to measure the optical density of a microorganism suspension.

Device Class : 2

Duns Number: 086785110

Premarket Exempt : No

Product Code : LON

Prescription Use : Yes

Device Count : 1

VITEK® MS - 03573026328573 Catalog Number :

Device Description : Cassette docking station needed for preparing sample loading in the VITEK 2 system

Device Class : 2

Duns Number: 086785110

Premarket Exempt : No

Product Code : PEX

Prescription Use : Yes

Device Count : 1

BACT/ALERT® VIRTUO® - 03573026369767 Catalog Number :

Device Description : VIRTUO is a fully automated modular system that performs blood culture testing

Device Class : 1

Duns Number: 086785110

Premarket Exempt : No

Product Code : MDB

Prescription Use : Yes

Device Count : 1

BACT/ALERT® VIRTUO® - 03573026369774 Catalog Number :

Device Description : VIRTUO is a fully automated modular system that performs blood culture testing

Device Class : 1

Duns Number: 086785110

Premarket Exempt : No

Product Code : MDB

Prescription Use : Yes

Device Count : 1

BACT/ALERT® MP Antimicrobial Supplement Kit - 03573026428853 Catalog Number :

Device Description : Designed for recovery and detection of mycobacteria from sterile body specimens Designed for recovery and detection of mycobacteria from sterile body specimens other than blood, and from digested/decontaminated clinical specimens.

Device Class : 1

Duns Number: 086785110

Premarket Exempt : No

Product Code : MDB

Prescription Use : Yes

Device Count : 1

VITEK® 2 YST - 03573026529697 Catalog Number :

Device Description : The VITEK® 2 YST Identification Card is intended for use with the VITEK 2 to det The VITEK® 2 YST Identification Card is intended for use with the VITEK 2 to determine ID of clinically important yeast and yeast-like organisms

Device Class : 1

Duns Number: 086785110

Premarket Exempt : Yes

Product Code : JXB

Prescription Use : Yes

Device Count : 1

VITEK® 2 NH - 03573026529710 Catalog Number :

Device Description : The VITEK® 2 NH Identification Card is intended for use with the VITEK 2 Systems The VITEK® 2 NH Identification Card is intended for use with the VITEK 2 Systems for ID of clinically important Neisseria, Haemophilus and other fastidious GN bacteria

Device Class : 1

Duns Number: 086785110

Premarket Exempt : Yes

Product Code : JST

Prescription Use : Yes

Device Count : 1

VITEK® 2 ANC - 03573026529727 Catalog Number :

Device Description : The VITEK® 2 ANC Identification Card is intended for use with the VITEK 2 System The VITEK® 2 ANC Identification Card is intended for use with the VITEK 2 Systems for ID of clinically important anaerobic bacteria and coryneform bacteria

Device Class : 1

Duns Number: 086785110

Premarket Exempt : Yes

Product Code : JSP

Prescription Use : Yes

Device Count : 1

VITEK® 2 AST-ST01 - 03573026529741 Catalog Number :

Device Description : The VITEK ® 2 Streptococcus Susceptibility Card is intended for use with the VIT The VITEK ® 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of S. pneumo , beta-hemolytic Strep, & Viridans Strep

Device Class : 2

Duns Number: 086785110

Premarket Exempt : No

Product Code : LON

Prescription Use : Yes

Device Count : 1

VITEK® 2 AST-YS05 - 03573026529758 Catalog Number :

Device Description : The VITEK 2 Fungal Susceptibility Card is intended for use with the VITEK 2 syst The VITEK 2 Fungal Susceptibility Card is intended for use with the VITEK 2 systems as an in vitro test to determine the susceptibility of clinically significant yeast to antifungal agents

Device Class : 2

Duns Number: 086785110

Premarket Exempt : No

Product Code : NGZ

Prescription Use : Yes

Device Count : 1

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