Sofia 20231
by Quidel Corp.
Sofia 20231 is a Class I device made by Quidel Corp., cleared under FDA 510(k) K123793 on 17 Jun 2013 and listed in FDA GUDID since 10 Nov 2018 (UDI-DI 30014613202318), 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 | Number30014613202318 | Date10 Nov 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK123793 | Date17 Jun 2013 | StatusActive |
Official records
- AccessGUDID record 30014613202318
- FDA 510(k) database K123793
Across registries
- FDA 510(k) K123793 decided 17 Jun 2013 Active
- FDA GUDID UDI-DI 30014613202318 listed 10 Nov 2018 Listed
Timeline
- Cleared FDA 510(k) K123793
- Listed FDA GUDID 30014613202318
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sofia
- Generic name
- Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
- Model / Ref / Catalog
- 20231
- Primary DI / UDI-DI
- 30014613202318
- 510(k) Number
- FDA product code
- GTY
- GMDN term
- Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
- Device class
- Class I
- Regulation number
- 866.3740
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical.