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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.
Classification Namekit, dna detection, human papillomavirus
Generic Namekit, dna detection, human papillomavirus
1201 clopper road
gaithersburg, MD 20878
PMA NumberP890064
Supplement NumberS009
Date Received10/01/2001
Decision Date03/31/2003
Product Code
MAQ[ Registered Establishments with MAQ ]
Docket Number 04M-0147
Notice Date 04/01/2004
Advisory Committee Microbiology
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the digene hybrid capture 2 (hc2) high-risk hpv dna test. The device is indicated for: 1) to screen patients with ascus (atypical squamous cells of undetermined significance) pap smear results to determine the need for referral to colposcopy. The results of this test are not intended to prevent women from proceeding to colposcopy. 2) in women 30 years and older the hc2 high-risk hpv dna test can be used with pap to adjunctively screen to assess the presence or absence of high-risk hpv types. This information, together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling