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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 16 18/45 Genotype Assay
Generic NameKit, rna detection, human papillomavirus
ApplicantGEN-PROBE INCORPORATED
10210 Genetic Center Drive
San Diego, CA 92121
PMA NumberP120007
Supplement NumberS020
Date Received03/18/2019
Decision Date04/28/2019
Product Code OYB 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for an alternate cleaning recommendation for the sample racks used on the Panther and Tigris instruments.
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