PMA P890064S008
- Device
- HCS HPV, HCII HPV
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S008
- Product code
- MAQ
- Decision date
- 2000-09-12
- Classification
- Kit, Dna Detection, Human Papillomavirus
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT DIGENE CORPORATION, GAITHERSBURG, MD, 20878.
Current openFDA PMA Record#
- Device
- HCS HPV, HCII HPV
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S008
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2000-09-12
- Decision code
- APPR
- Date received
- 2000-08-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT DIGENE CORPORATION, GAITHERSBURG, MD, 20878.