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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 NameCOBAS HPV TEST, 240 TESTS; COBAS HPV TEST 960 TESTS
Classification Namekit, dna detection, human papillomavirus
Generic Namehuman papillomavirus dna test detection kit
ApplicantROCHE MOLECULAR SYSTEMS, INC.
PMA NumberP100020
Supplement NumberS012
Date Received11/06/2013
Decision Date12/16/2013
Product Code
MAQ[ Registered Establishments with MAQ ]
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 a change to the software of the cobas z480 amplification/ detection analyzer, which is a component of the cobas 4800 system.
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