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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/APTIMA 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 NumberS003
Date Received03/31/2010
Decision Date04/23/2010
Reclassified Date 12/22/2021
Product Code MZP 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE OF LOCATION FOR A QC LAB TO SEGREGATE THE PRE- AND POST-AMPLIFICATION STEPS INTO SEPARATE ROOMS.
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