FDA-Device2019-06-12Class II
MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.
Bio-Rad Laboratories, Inc
Hazard
Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.
Sold states
US Nationwide Distribution to: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico.
Affected count
5,212 units
Manufactured in
6565 185th Ave Ne, Redmond, WA, United States
Products
MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1742-2019Don't want to check this manually?
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