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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
Classification Namekit, dna detection, human papillomavirus
Generic Namehuman papillomavirus dna test detection kit
ApplicantROCHE MOLECULAR SYSTEMS, INC.
PMA NumberP100020
Supplement NumberS011
Date Received08/14/2013
Decision Date09/12/2013
Product Code
MAQ[ Registered Establishments with MAQ ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the oligonucleotide manufacturing process for the devices.
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