FDA-Device2025-11-26Class IIMISBRANDING
Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version: N/A Product Description: Measles IgG tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgG antibodies against measles virus in a patient's serum or plasma Component: not a component
Hazard
Due to distributing the measles IgG IVD without a premarket approved/cleared.
Intended for
All ages
Illnesses reported
None reported
Sold states
All products were distributed in the United States. (Utah, Washington).
Manufactured in
8127 Nw 29th St, Doral, FL, United States
Products
Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version: N/A Product Description: Measles IgG tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgG 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-0534-2026Want us to check the next one for you?
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