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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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PMA Number P110037 Decision Date To 05/25/2015
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COBAS AmpliPrep/COBAS TaqMan CMV Test Roche Molecular Systems, Inc. P110037 S030 08/09/2017
COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM ... Roche Molecular Systems, Inc. P110037 S031 08/11/2017
COBAS AmpliPrep/COBAS TaqMan Cytomegalovirus Test Roche Molecular Systems, Inc. P110037 S032 10/13/2017
Cobas AmpliPrep/Cobas TaqMan CMV Test Roche Molecular Systems, Inc. P110037 S033 12/20/2017
Cobas AmpliPrep/Cobas TaqMan CMV Test Roche Molecular Systems, Inc. P110037 S034 03/26/2018
Cobas AmpliPrep/Cobas TaqMan CMV Test Roche Molecular Systems, Inc. P110037 S035 05/15/2018
Cobas AmpliPrep/Cobas TaqMan CMV Test Roche Molecular Systems, Inc. P110037 S036 05/04/2018
COBAS AmpliPrep/COBAS TaqMan Cytomegalovirus Test Roche Molecular Systems, Inc. P110037 S037 07/03/2018
COBAS AmpliPrep/COBAS TaqMan CMV Test Roche Molecular Systems, Inc. P110037 S038 07/05/2018
COBAS AmpliPrep/COBAS TaqMan CMV Test Roche Molecular Systems, Inc. P110037 S039 07/26/2018
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