DIGENE HYBRID CAPTURE2
FDA premarket approval P890064/S020 · decided 2009-08-12
Approval details
- PMA number
- P890064
- Supplement
- S020
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DIGENE HYBRID CAPTURE2
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Qiagen Gaithersburg, Inc.
- Date received
- 2008-01-29
- Decision date
- 2009-08-12
- Days to decision
- 561 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT TURNER BIOSYSTEMS IN SUNNYVALE, CALIFORNIA, TO MANUFACTURE THE DML 3000¿ MICROPLATE LUMINOMETER WHICH IS INTENDED FOR USE WITH THE HYBRID CAPTURE 2 HIGH RISK HPV DNA TEST AND HYBRID CAPTURE 2 HPV DNA TEST.
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