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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 HBV Quant Assay
Generic NameHepatitis Viral B DNA Detection
Regulation Number866.3174
ApplicantHologic, Inc.
10210 Genetic Center Dr.
San Diego, CA 92121
PMA NumberP170025
Supplement NumberS004
Date Received05/11/2018
Decision Date10/16/2018
Reclassified Date10/20/2025
Product Code MKT 
Advisory Committee Microbiology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the transfer of bulk reagent manufacturing to another facility.
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