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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 9 of 9 Results
productcode PAB PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
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cobas CMV ROCHE MOLECULAR SYSTEMS, INC. P160041 S035 12/14/2022
Alinity m CMV Abbott Molecular, Inc. P210022 S002 11/28/2022
COBAS® AmpliPrep/ COBAS® TaqMan® CMV Test Roche Molecular Systems, Inc. P110037 S057 11/14/2022
Aptima CMV Quant Assay Hologic, Inc. P210029 S001 07/20/2022
Abbott RealTime CMV Amplification Kit (09N21-090),... ABBOTT MOLECULAR P160044 S004 06/09/2022
Alinity m CMV Abbott Molecular, Inc. P210022 S001 05/26/2022
Aptima CMV Quant Assay Hologic, Inc. P210029 05/09/2022
Alinity m CMV Abbott Molecular, Inc. P210022 05/05/2022
Cobas CMV ROCHE MOLECULAR SYSTEMS, INC. P160041 S034 01/19/2022
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