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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 HPV ASSAY
Generic NameKit, rna detection, human papillomavirus
ApplicantGEN-PROBE INCORPORATED
10210 Genetic Center Drive
San Diego, CA 92121
PMA NumberP100042
Supplement NumberS023
Date Received03/27/2019
Decision Date04/26/2019
Product Code OYB 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
a change in plastic resin used for reagent storage containers
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