FDA-Device2021-05-19Class II
Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screening method for primary isolation and presumptive identification of vancomycin-resistance enterococci (VRE) from surveillance cultures.
Remel Inc
Hazard
The media allows growth of E. faecalis ATCC 29212 with blackening of the media.
Sold states
US Nationwide distribution in the states of AZ, CA, CO, CT, GA, IA, IL, IN, MA, MI, MN, MO, NC, ND, OH, OR, PA, SD, TN, TX, and VA. There was government distribution and no military or foreign distribution.
Affected count
91/10-test units
Manufactured in
12076 Santa Fe Trail Dr, Lenexa, KS, United States
Products
Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screening method for primary isolation and presumptive identification of vancomycin-resistance enterococci (VRE) from surveillance cultures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1561-2021Don't want to check this manually?
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