PMA P890064S041
- Device
- digene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S041
- Product code
- MAQ
- Decision date
- 2020-06-18
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- Alternate supplier for PCB.
Current openFDA PMA Record#
- Device
- digene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S041
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2020-06-18
- Decision code
- OK30
- Date received
- 2020-05-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate supplier for PCB.