PMA P890064S037
- Device
- digene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S037
- Product code
- MAQ
- Decision date
- 2018-02-21
- Classification
- Kit, Dna Detection, Human Papillomavirus
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- Modify the in-process QC methods as described and alter the component specifications for the specified reagent.
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
- S037
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2018-02-21
- Decision code
- OK30
- Date received
- 2018-01-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify the in-process QC methods as described and alter the component specifications for the specified reagent.