FDA-Device2025-09-17Class II
Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software Version: N/A Product Description: Measles IgM tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgM antibodies against measles virus in a patient's serum or plasma Component: not a component
Quest International, Inc.
Hazard
Measles IgM Test Kit lacks premarket approval or clearance.
Sold states
US Nationwide distribution in the states of Utah, Texas, and Arizona.
Affected count
376 kits
Manufactured in
8127 Nw 29th St, N/A, Doral, FL, United States
Products
Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software Version: N/A Product Description: Measles IgM tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgM antibodies against measles virus in a patient's serum or plasma Component: not a component
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2552-2025Don't want to check this manually?
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