PMA P890064S033
- Device
- digene Hybrid Capture 2 (HC2) HPV DNA Test and digene Hybrid Capture 2 (HC2) High Risk
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S033
- Product code
- MAQ
- Decision date
- 2016-04-15
- Classification
- Kit, Dna Detection, Human Papillomavirus
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- Approval for a new version of the HC2 Software Suite (version 4.4) and a new hardware model of the PC used with this software.
Current openFDA PMA Record#
- Device
- digene Hybrid Capture 2 (HC2) HPV DNA Test and digene Hybrid Capture 2 (HC2) High Risk
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S033
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2016-04-15
- Decision code
- APPR
- Date received
- 2016-02-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a new version of the HC2 Software Suite (version 4.4) and a new hardware model of the PC used with this software.