FDA-Device2022-12-07Class II
CMV IgM EIA, in vitro diagnostic.
Bio-Rad Laboratories, Inc.
Hazard
Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
Sold states
U.S.: CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, and TX O.U.S.: None
Affected count
180 kits
Manufactured in
6565 185th Ave Ne, Redmond, WA, United States
Products
CMV IgM EIA, in vitro diagnostic.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0342-2023Don't want to check this manually?
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