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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: OraQuick HCV Rapid Antibody Test
Classification Name: ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS
Product Code: MZO
Device Class: 3
Registered Establishment Name: ORASURE TECHNOLOGIES INC.
Registered Establishment Number: 3004142665
Owner/Operator: ORASURE TECHNOLOGIES, INC.
Owner/Operator Number: 9000083
Establishment Operations: Manufacturer; U.S. Manufacturer of Export Only Devices
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