| 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. |
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| Trade Name | DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST |
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| Classification Name | kit, dna detection, human papillomavirus |
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| Generic Name | human papillomavirus dna detection kit |
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| Applicant | DIGENE DIAGNOSTICS, INC. |
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| PMA Number | P890064 |
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| Supplement Number | S009 |
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| Date Received | 10/01/2001 |
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| Decision Date | 03/31/2003 |
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| Product Code | |
| Docket Number | 04M-0147 |
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| Notice Date | 04/01/2004 |
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| Advisory Committee |
Microbiology |
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| Supplement Type | panel track |
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| Supplement Reason | labeling change - indications |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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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
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