BIOMERIEUX , INC.

Address:595 ANGLUM RD.,HAZELWOOD,MO,63042,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, Test, Automated, Antimicrobial Susceptibility, Short Incubation (LON) (5) SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION (LON) (2) Tubes, Vacuum Sample, With Anticoagulant (GIM) (2) Susceptibility test cards, antimicrobial (LTW) (1) System, blood culturing (MDB) (1)

Premarket Exempt

No Yes

Clear

VITEK®2 - 03573026553968 Catalog Number :

Device Description : VITEK ® 2 software 8.01 update, advanced software to run your VITEK ® 2 system

Device Class : 2

Duns Number: 086785110

Premarket Exempt : No

Product Code : LON

Prescription Use : Yes

Device Count : 1

VITEK® 2 AST-GP78 - 03573026554569 Catalog Number :

Device Description : VITEK ® 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 VITEK ® 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae

Device Class : 2

Duns Number: 086785110

Premarket Exempt : No

Product Code : LON

Prescription Use : Yes

Device Count : 1

VITEK® 2 AST-ST02 - 03573026554613 Catalog Number :

Device Description : The VITEK® 2 Streptococcus Susceptibility Card is intended for use with the VITE The VITEK® 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of S. pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus

Device Class : 2

Duns Number: 086785110

Premarket Exempt : No

Product Code : LON

Prescription Use : Yes

Device Count : 1

VITEK®2 - 03573026555504 Catalog Number :

Device Description : VITEK®2 software 9.01.0, advanced software to run your VITEK®2 system

Device Class : 2

Duns Number: 086785110

Premarket Exempt : No

Product Code : LON

Prescription Use : Yes

Device Count : 1

BacT/ALERT® Blood Collection Adapter Cap - 03573026556105 Catalog Number :

Device Description : The BacT/ALERT Blood Collection Adapter is used as an aid to facilitate filling The BacT/ALERT Blood Collection Adapter is used as an aid to facilitate filling of blood into the BacT/ALERT Blood Culture Bottle when using a blood collection set

Device Class :

Duns Number: 086785110

Premarket Exempt : No

Product Code : GIM

Prescription Use : Yes

Device Count : 120

BacT/ALERT® Blood Collection Adapter Insert - 03573026556129 Catalog Number :

Device Description : The Adapter Insert is used with The BacT/ALERT Blood Collection Adapter. It can The Adapter Insert is used with The BacT/ALERT Blood Collection Adapter. It can be locked inside the Adapter Cap to allow blood to be filled into vacuum collection tubes.

Device Class :

Duns Number: 086785110

Premarket Exempt : No

Product Code : GIM

Prescription Use : Yes

Device Count : 60

VITEK® 2 0,45% Sodium Chloride Diluent - 03573026556969 Catalog Number :

Device Description : VITEK 2.0 0.45% SALINE INDIVIDUAL BAG

Device Class : 2

Duns Number: 086785110

Premarket Exempt : No

Product Code : LON, LTW

Prescription Use : Yes

Device Count : 1

VITEK® 2 AST-GN95 - 03573026563844 Catalog Number :

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 gramnegative bacilli

Device Class : 2

Duns Number: 086785110

Premarket Exempt : No

Product Code : LON

Prescription Use : Yes

Device Count : 1

VITEK® 2 AST-XN08 - 03573026565381 Catalog Number :

Device Class : 2

Duns Number: 086785110

Premarket Exempt : No

Product Code : LON

Prescription Use : Yes

Device Count : 1

BACT/ALERT® PF - 03573026595722 Catalog Number :

Device Description : BACT/ALERT® PF Culture Bottles are used in qualitative procedures for recovery a BACT/ALERT® PF Culture Bottles are used in qualitative procedures for recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood

Device Class : 1

Duns Number: 086785110

Premarket Exempt : No

Product Code : MDB

Prescription Use : Yes

Device Count : 1

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