DIGENE HYBRID CAPTURE 2 HPV DNA TEST
FDA premarket approval P890064/S012 · decided 2003-06-20
Approval details
- PMA number
- P890064
- Supplement
- S012
- Supplement type
- Special (Immediate Track)
- Trade name
- DIGENE HYBRID CAPTURE 2 HPV DNA TEST
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Qiagen Gaithersburg, Inc.
- Date received
- 2003-05-20
- Decision date
- 2003-06-20
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- APPROVAL FOR MODIFICATION OF LOT RELEASE TESTING FOR DETECTION REAGENT 1 (DR1) COMPONENT.
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