PMA P890064S034
- Device
- digene HC2 High Risk HPV DNA Test
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S034
- Product code
- MAQ
- Decision date
- 2017-07-25
- Classification
- Kit, Dna Detection, Human Papillomavirus
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- Change a current quality control functional testing procedure.
Current openFDA PMA Record#
- Device
- digene HC2 High Risk HPV DNA Test
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S034
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2017-07-25
- Decision code
- OK30
- Date received
- 2017-06-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change a current quality control functional testing procedure.