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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: VERSANT HCV RNA Qualitative Assay
Classification Name: ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS
Product Code: MZP
Device Class: 3
Registered Establishment Name: Hologic, Inc
Registered Establishment Number: 2032600
Owner/Operator: HOLOGIC, INC.
Owner/Operator Number: 9007676
Establishment Operations: Manufacturer
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