- Device
- DML 3000 Microplate Luminometer, 5000-00031, digene® HC2 High-Risk HPV DNA Test (I plate), 5199-1220, digene® HC2 High-R
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S042
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2023-10-19
- Decision code
- OK30
- Date received
- 2023-09-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a supplier manufacturing site relocation for a test component