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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 TaqMan HCV Test; COBAS AmpliPrep/COBAS TaqMan HCV Test, version 2.0; COBAS TaqMan HCV Test, version 2 For Use With The High Pure System
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 MOLECULAR SYSTEMS, INC.
Registered Establishment Number: 2243471
Owner/Operator: ROCHE MOLECULAR SYSTEMS, INC.
Owner/Operator Number: 2243471
Establishment Operations: Manufacturer
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