digene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test
FDA premarket approval P890064/S039 · decided 2018-03-16
Approval details
- PMA number
- P890064
- Supplement
- S039
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- digene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Qiagen Gaithersburg, Inc.
- Date received
- 2018-02-16
- Decision date
- 2018-03-16
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- Modification of QC testing for a critical subcomponent of the test.
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