PMA P890064S031
- Device
- DIGENE HC2 SYSTEM SOFTWARE
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S031
- Product code
- MAQ
- Decision date
- 2014-10-09
- Classification
- Kit, Dna Detection, Human Papillomavirus
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- APPROVAL FOR THE UPGRADE OF THE HC2 SOFTWARE SUITE TO VERSION 4.3.
Current openFDA PMA Record#
- Device
- DIGENE HC2 SYSTEM SOFTWARE
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S031
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2014-10-09
- Decision code
- APPR
- Date received
- 2014-09-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE UPGRADE OF THE HC2 SOFTWARE SUITE TO VERSION 4.3.