DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TESTS
FDA premarket approval P890064/S032 · decided 2015-05-29
Approval details
- PMA number
- P890064
- Supplement
- S032
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TESTS
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Qiagen Gaithersburg, Inc.
- Date received
- 2015-04-28
- Decision date
- 2015-05-29
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN PENANG, MALAYSIA.
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