FDA-Device2019-06-12Class II
MRSASelect II, IVD, REF 63758 (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
3,632 units
Manufactured in
6565 185th Ave Ne, Redmond, WA, United States
Products
MRSASelect II, IVD, REF 63758 (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-1743-2019Don't want to check this manually?
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