PMA P890064S036
- Device
- digene Hybird Capture 2 (HC2) HPV DNA Test
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S036
- Product code
- MAQ
- Decision date
- 2018-02-08
- Classification
- Kit, Dna Detection, Human Papillomavirus
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- Update and tighten final kit release criteria.
Current openFDA PMA Record#
- Device
- digene Hybird Capture 2 (HC2) HPV DNA Test
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S036
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2018-02-08
- Decision code
- OK30
- Date received
- 2018-01-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update and tighten final kit release criteria.