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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 NameDIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & HIGH RISK HPV DNA TEST
Classification Namekit, dna detection, human papillomavirus
Generic Namehuman papillomavirus dna detection kit
ApplicantQIAGEN GAITHERSBURG, INC
PMA NumberP890064
Supplement NumberS025
Date Received02/28/2011
Decision Date03/29/2011
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 
Changes for digene® hybrid capture 2 (hc2) hpv dna test and digene® hybrid capture 2 (hc2) high risk hpv dna test located in gaithersburg, md.
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