DIGENE HYBRID CAPTURE HPV DNA TEST
FDA premarket approval P890064/S017 · decided 2004-12-14
Approval details
- PMA number
- P890064
- Supplement
- S017
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DIGENE HYBRID CAPTURE HPV DNA TEST
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Qiagen Gaithersburg, Inc.
- Date received
- 2004-11-19
- Decision date
- 2004-12-14
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- APPROVAL FOR PACKAGING QUALITY CONTROL MATERIAL IN THE HYBRID CAPTURE 2 HPV DNA TEST KITS THAT WAS PREVIOUSLY PROVIDED UNDER A SEPARATE PRODUCT CODE, AS WELL AS THE ADDITION OF AN UPPER LIMIT FOR THE HPV POSITIVE CONTROL TEST VALUES.
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