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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 Quant Dx Assay
Generic NameAssay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Regulation Number866.3170
ApplicantHOLOGIC, INC.
10210 Genetic Center Dr
SAN DIEGO, CA 92121
PMA NumberP160023
Supplement NumberS006
Date Received08/31/2018
Decision Date09/26/2018
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  
Implementation of additional in-process testing and associated specifications for lyophilized kit reagents.
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