HYBRID CAPTURE(TM) SYSTEM HPV DNA ASSAY
FDA premarket approval P890064/S005 · decided 1997-08-15
Approval details
- PMA number
- P890064
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HYBRID CAPTURE(TM) SYSTEM HPV DNA ASSAY
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Qiagen Gaithersburg, Inc.
- Date received
- 1996-11-01
- Decision date
- 1997-08-15
- Days to decision
- 287 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- Approval for use of a cervical broom specimen collected and transported in the Cytyc Corporation PreservCyt(R) Solution for testing in the Digene Corporation Hybrid Capture(TM) System HPV DNA Assay.
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