HCS HPV, HCII HPV
FDA premarket approval P890064/S008 · decided 2000-09-12
Approval details
- PMA number
- P890064
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- HCS HPV, HCII HPV
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Qiagen Gaithersburg, Inc.
- Date received
- 2000-08-25
- Decision date
- 2000-09-12
- Days to decision
- 18 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT DIGENE CORPORATION, GAITHERSBURG, MD, 20878.
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