digene HC2 High-Risk HPB DNA Test and digene HC2 HPV DNA Test
FDA premarket approval P890064/S038 · decided 2018-03-14
Approval details
- PMA number
- P890064
- Supplement
- S038
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- digene HC2 High-Risk HPB 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
- 2018-03-14
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- Change in-process QC testing and sampling of a raw material used to manufacture kit subcomponents.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.