PMA P890064S040
- Device
- HC2 High-Risk HPV DNA Test and digene / HC2 HPV DNA Test
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S040
- Product code
- MAQ
- Decision date
- 2018-03-27
- Classification
- Kit, Dna Detection, Human Papillomavirus
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- Update in-process QC-testing procedures for a critical component.
Current openFDA PMA Record#
- Device
- HC2 High-Risk HPV DNA Test and digene / HC2 HPV DNA Test
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S040
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2018-03-27
- Decision code
- OK30
- Date received
- 2018-02-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update in-process QC-testing procedures for a critical component.