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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 AND DNA EXTENSION KIT
Classification Namekit, dna detection, human papillomavirus
ApplicantHOLOGIC, INC.
PMA NumberP080014
Supplement NumberS003
Date Received09/16/2010
Decision Date10/06/2010
Product Code
MAQ[ Registered Establishments with MAQ ]
Advisory Committee Microbiology
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for several changes to the invader call reporter and cervista hpv hr software on the separate cds with new part numbers.
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