DML 3000 Microplate Luminometer, 5000-00031, digene® HC2 High-Risk HPV DNA Test (I plate), 5199-1220, digene® HC2 High-R
FDA premarket approval P890064/S042 · decided 2023-10-19
Approval details
- PMA number
- P890064
- Supplement
- S042
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DML 3000 Microplate Luminometer, 5000-00031, digene® HC2 High-Risk HPV DNA Test (I plate), 5199-1220, digene® HC2 High-R
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Qiagen Gaithersburg, Inc.
- Date received
- 2023-09-29
- Decision date
- 2023-10-19
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- a supplier manufacturing site relocation for a test component
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