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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.
Classification Namekit, dna detection, human papillomavirus
Generic Namehuman papillomavirus dna test detection kit
PMA NumberP100020
Supplement NumberS004
Date Received06/14/2012
Decision Date06/25/2013
Product Code
MAQ[ Registered Establishments with MAQ ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for processing of residual cervical sample directly from the preservcyt¿ vial (hologic, inc. , bedford, ma) after processing for liquid-based cytology (lbc) using either the hologic thinprep® 2000 or thinprep® 3000 processors and testing on the cobas® 4800 system directly from the preservcyt vial (primary vial). Approval for capability to add optional non-ivd software to the cobas® 4800 system that is used to perform the cobas® hpv test was also requested.