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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST
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: ROCHE DIAGNOSTICS LTD.
Registered Establishment Number: 3003795116
Owner/Operator: Roche Diagnostics GmbH & Roche Diagnostics AG
Owner/Operator Number: 9039767
Establishment Operations: Manufacturer
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