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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 CMV
Generic NameCytomegalovirus (cmv) dna quantitative assay
Regulation Number866.3180
ApplicantRoche Molecular Systems, Inc.
4300 Hacienda Dr.
Pleasanton, CA 94588
PMA NumberP160041
Supplement NumberS035
Date Received05/31/2022
Decision Date12/14/2022
Reclassified Date10/23/2024
Product Code PAB 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the cobas CMV migration from cobas 6800/8800 to the cobas 5800.
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