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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCobas AmpliPrep and Cobas TaqMan CMV Test
Generic NameCytomegalovirus (cmv) dna quantitative assay
Regulation Number866.3180
ApplicantRoche Molecular Systems, Inc.
4300 Hacienda Dr.
Pleasanton, CA 94588
PMA NumberP110037
Supplement NumberS050
Date Received09/20/2019
Decision Date10/10/2019
Reclassified Date10/23/2024
Product Code PAB 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Implement an alternate spectrophotometer for in-process QC testing.
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