Sofia hCG FIA
Sofia hCG FIA (20266) is a human chorionic gonadotropin beta-subunit IVD (FDA Class II; FDA product code JHI, Visual, pregnancy hCG, prescription use) made by Quidel Corp., cleared under FDA 510(k) K131166 on 2 Aug 2013 and listed in FDA GUDID since 15 Sep 2016 (UDI-DI 30014613202660), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number30014613202660 | Date15 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK131166 | Date2 Aug 2013 | StatusActive |
Official records
- AccessGUDID record 30014613202660
- FDA 510(k) database K131166
Across registries
- FDA 510(k) K131166 decided 2 Aug 2013 Active
- FDA GUDID UDI-DI 30014613202660 listed 15 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K131166
- Listed FDA GUDID 30014613202660
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sofia
- Generic name
- Human chorionic gonadotropin beta-subunit IVD, kit, rapid ICT, clinical
- Model / Ref / Catalog
- hCG FIA, 20266
- Primary DI / UDI-DI
- 30014613202660
- 510(k) Number
- FDA product code
- JHI
- GMDN term
- Human chorionic gonadotropin beta-subunit IVD, kit, rapid ICT, clinical
- Device class
- Class II
- Regulation number
- 862.1155
- GUDID distribution status
- In Commercial Distribution