VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT
FDA premarket approval P890064/S002 · decided 1994-05-19
Approval details
- PMA number
- P890064
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Qiagen Gaithersburg, Inc.
- Date received
- 1992-12-09
- Decision date
- 1994-05-19
- Days to decision
- 526 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
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