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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.
 
DeviceVERSANT HCV Genotype 2.0 Assay (LiPA)
Generic Nameassay, genotyping, hepatitis c virus
Regulation Number866.3170
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS, INC.
p.o. box 2466
berkeley, CA 94702-2466
PMA NumberP160016
Supplement NumberS006
Date Received07/31/2020
Decision Date08/27/2020
Reclassified Date 12/22/2021
Product Code OBF 
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Manufacturing process change to replace with new RNA QC samples.
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