PMA P890064S026
- Device
- DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & DIGENE HYBRID CAPTURE CAPTURE 2 (HC2) HIGH HPV DNA TEST
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S026
- Product code
- MAQ
- Decision date
- 2011-04-20
- Classification
- Kit, Dna Detection, Human Papillomavirus
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- APPROVAL FOR SOFTWARE DESIGN CHANGE OF THE HC2 SYSTEM SUITE CONSISTING OF AN HC2 SYSTEM SOFTWARE UPGRADE FROM VERSION 2.0 TO VERSION 3.0.
Current openFDA PMA Record#
- Device
- DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & DIGENE HYBRID CAPTURE CAPTURE 2 (HC2) HIGH HPV DNA TEST
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S026
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2011-04-20
- Decision code
- APPR
- Date received
- 2011-02-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SOFTWARE DESIGN CHANGE OF THE HC2 SYSTEM SUITE CONSISTING OF AN HC2 SYSTEM SOFTWARE UPGRADE FROM VERSION 2.0 TO VERSION 3.0.