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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 HBV
Generic Namehepatitis viral b dna detection
Applicant
Roche Molecular Systems, Inc.
4300 hacienda drive
pleasanton, CA 94588-2722
PMA NumberP150014
Supplement NumberS037
Date Received07/24/2020
Decision Date11/02/2020
Product Code MKT 
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the cobas HBV Assay Specific Analytical Package (ASAP) software for use with the cobas HBV test and cobas HCV ASAP software for use with the cobas HCV test for use with the cobas 6800/8800.
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