DIGENE HYBRID CAPTURE II HIGH-RISK HPV DNA TEST
FDA premarket approval P890064/S007 · decided 2000-03-16
Approval details
- PMA number
- P890064
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DIGENE HYBRID CAPTURE II HIGH-RISK HPV DNA TEST
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Qiagen Gaithersburg, Inc.
- Date received
- 2000-02-07
- Decision date
- 2000-03-16
- Days to decision
- 38 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- Approval for removal of the reagent component "Probe A" and Indication number 1. The device, as modified, will be marketed under the trade name Digene High-Risk HPV DNA Test using Hybrid Capture.
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