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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.
 
DeviceAPTIMA 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 NumberS006
Date Received12/18/2012
Decision Date01/09/2013
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  
MODIFICATION TO THE QUALITY CONTROL RELEASE TESTING FOR THE REAGENTS KITS.
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