FDA-Device2013-04-03Class II
bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents.
Biomerieux Inc
Hazard
The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.
Sold states
Distributed only in HI.
Affected count
4/20-card cartons
Manufactured in
595 Anglum Rd, Hazelwood, MO, United States
Products
bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1013-2013Don't want to check this manually?
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