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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 NameCERVISTA HPV HR TEST
Classification Namekit, dna detection, human papillomavirus
ApplicantHOLOGIC, INC.
PMA NumberP080014
Supplement NumberS006
Date Received12/30/2010
Decision Date01/20/2011
Product Code
MAQ[ Registered Establishments with MAQ ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of an alternative vendor for cervista® hpv oligos mix 1, mix 2, mix 3 used in the cervista® hpv hr test.
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