PMA P890064S012
- Device
- DIGENE HYBRID CAPTURE 2 HPV DNA TEST
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S012
- Product code
- MAQ
- Decision date
- 2003-06-20
- Classification
- Kit, Dna Detection, Human Papillomavirus
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- APPROVAL FOR MODIFICATION OF LOT RELEASE TESTING FOR DETECTION REAGENT 1 (DR1) COMPONENT.
Current openFDA PMA Record#
- Device
- DIGENE HYBRID CAPTURE 2 HPV DNA TEST
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S012
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2003-06-20
- Decision code
- APPR
- Date received
- 2003-05-20
- Supplement type
- Special (Immediate Track)
- Approval order statement
- APPROVAL FOR MODIFICATION OF LOT RELEASE TESTING FOR DETECTION REAGENT 1 (DR1) COMPONENT.