BIOMERIEUX , INC.

Address:595 ANGLUM RD.,HAZELWOOD,MO,63042,US

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Device Description : The DISPLAY is part of the VITEK DensiCHEK that allows to read the McFarland val The DISPLAY is part of the VITEK DensiCHEK that allows to read the McFarland value for a bacterial suspension. It is used for the Vitek instrument to prepare ID and AST test.

Device Class : 2

Duns Number: 086785110

Premarket Exempt : No

Product Code : LON

Prescription Use : Yes

Device Count : 1

Device Description : VITEK DENSICHEK CONNECTIVITY BASE Kit that include one pod and one connecrtivity base

Device Class : 2

Duns Number: 086785110

Premarket Exempt : No

Product Code : LON

Prescription Use : Yes

Device Count : 1

Device Description : BacT/ALERT Worksafe Collection Kit contains most of the items to facilitate bloo BacT/ALERT Worksafe Collection Kit contains most of the items to facilitate blood culture collection. This kit contains FA Plus Aerobic and FN Plus Anaerobic Bottles.

Device Class : 1

Duns Number: 086785110

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : Yes

Device Count : 1

Device Description : BacT/ALERT Worksafe Collection Kit contains most of the items to facilitate bloo BacT/ALERT Worksafe Collection Kit contains most of the items to facilitate blood culture collection. This kit contains FA Plus Aerobic and Standard Anaerobic Bottles.

Device Class : 1

Duns Number: 086785110

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : Yes

Device Count : 1

Device Description : BacT/ALERT Worksafe Collection Kit contains most of the items to facilitate bloo BacT/ALERT Worksafe Collection Kit contains most of the items to facilitate blood culture collection. This kit contains FA Plus Pediatric Bottle.

Device Class : 1

Duns Number: 086785110

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : Yes

Device Count : 1

Device Description : The POD is part of the VITEK DensiCHEK that allows to read the McFarland value f The POD is part of the VITEK DensiCHEK that allows to read the McFarland value for a bacterial suspension. It is used for the Vitek instrument to prepare ID and AST test.

Device Class : 2

Duns Number: 086785110

Premarket Exempt : No

Product Code : LON

Prescription Use : Yes

Device Count : 1

Device Description : VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli

Device Class : 2

Duns Number: 086785110

Premarket Exempt : No

Product Code : LON

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : CD WITH 9.02 software version

Device Class : 2

Duns Number: 086785110

Premarket Exempt : No

Product Code : LON

Prescription Use : Yes

Device Count : 1

Device Description : VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli

Device Class : 2

Duns Number: 086785110

Premarket Exempt : No

Product Code : LON

Prescription Use : Yes

Device Count : 1

Device Description : BACT/ALERT BPA (aerobic culture) bottles are used for QC testing of leukocyte re BACT/ALERT BPA (aerobic culture) bottles are used for QC testing of leukocyte reduced apheresis platelet units,leukocyte reduced single units of whole blood platelet concentrates

Device Class :

Duns Number: 086785110

Premarket Exempt : No

Product Code : MZC

Prescription Use : Yes

Device Count : 1