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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 NameROCHE COBAS HPV TEST
Classification Namekit, dna detection, human papillomavirus
Generic Namehuman papillomavirus dna test detection kit
ApplicantROCHE MOLECULAR SYSTEMS, INC.
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.
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