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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 RNA QUALITATIVE ASSAY
Generic NameAssay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Regulation Number866.3170
ApplicantGEN-PROBE
10210 GENETIC CENTER DR.
SAN DIEGO, CA 92121
PMA NumberP020011
Supplement NumberS005
Date Received04/05/2012
Decision Date06/25/2012
Reclassified Date 12/22/2021
Product Code MZP 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A DEVICE NAME CHANGE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VERSANT HCV RNA QUALITATIVE ASSAY AND APTIMA HCV RNA QUALITATIVE ASSAY AND IS INDICATED FOR THE DETECTION OF HEPATITIS C VIRUS (HCV) RNA IN HUMAN PLASMA (EDTA, SODIUM HEPARIN, SODIUM CITRATE, AND ACD) OR SERUM.
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