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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: COVID-19 IgG/IgM Rapid Test
Classification Name: REAGENT, CORONAVIRUS SEROLOGICAL
Product Code: QKO
Device Class: Not Classified
Registered Establishment Name: Biomerica
Registered Establishment Number: 2025099
Owner/Operator: Biomerica, Inc.
Owner/Operator Number: 10023649
Establishment Operations: U.S. Manufacturer of Export Only Devices
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