FDA-Device2022-12-07Class II
CMV IgM EIA, in vitro diagnostic.
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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