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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameAPTIMA HPV 16 18/45 GENETYPE ASSAY
Classification Namekit, rna detection, human papillomavirus
ApplicantGEN-PROBE INCORPORATED
PMA NumberP120007
Supplement NumberS002
Date Received04/17/2014
Decision Date04/29/2014
Product Code
OYB[ Registered Establishments with OYB ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the minor software changes for the aptima hpv assay software (v2. 3. 5), the aptima hpv-gt assay software (v2. 7. 5), panther system software (v5. 2).
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