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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 AND DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST
Classification Namekit, dna detection, human papillomavirus
Generic Namehuman papillomavirus dna detection kit
ApplicantQIAGEN GAITHERSBURG, INC
PMA NumberP890064
Supplement NumberS021
Date Received02/03/2010
Decision Date03/31/2010
Product Code
MAQ[ Registered Establishments with MAQ ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a trade name change for the hybrid capture 2 (hc2) high-risk hpv dna test and hybrid capture 2 (hc2) hpv dna test. The devices, as modified, will be marketed under the trade name digene hybrid capture 2 (hc2) high-risk hpv dna test and digene hybrid capture 2 (hc2) hpv dna test and are indicated for the qualitative detection of specified types of human papillomavirus (hpv) dna in cervical specimens.
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