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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 CMV Test
Classification Name: CYTOMEGALOVIRUS (CMV) DNA QUANTITATIVE ASSAY
Product Code: PAB
Device Class: 3
Registered Establishment Name: ROCHE MOLECULAR SYSTEMS, INC.
Registered Establishment Number: 3004141078
Owner/Operator: ROCHE MOLECULAR SYSTEMS, INC.
Owner/Operator Number: 2243471
Establishment Operations: Specification Developer
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