FDA-Device2015-05-20Class II
Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.
Biomerieux Inc
Hazard
The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258.
Sold states
Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.
Affected count
1604/20-card cartons
Manufactured in
595 Anglum Rd, N/A, Hazelwood, MO, United States
Products
Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1603-2015Don't want to check this manually?
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