FDA-Device2016-05-18Class I
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Biomerieux Inc
Hazard
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Sold states
Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.
Affected count
1,524 kits
Manufactured in
595 Anglum Rd, N/A, Hazelwood, MO, United States
Products
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1646-2016Don't want to check this manually?
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