Sofia 20298
by Quidel Corp.
Sofia 20298 is a Class II device made by Quidel Corp., listed in FDA GUDID since 7 Aug 2018 (UDI-DI 30014613202981), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number30014613202981 | Date7 Aug 2018 | StatusListed |
Official records
- AccessGUDID record 30014613202981
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Sofia
- Generic name
- Borrelia burgdorferi total antibody IVD, kit, fluorescent immunoassay
- Model / Ref / Catalog
- 20298
- Primary DI / UDI-DI
- 30014613202981
- FDA product code
- LSR
- GMDN term
- Borrelia burgdorferi total antibody IVD, kit, fluorescent immunoassay
- Device class
- Class II
- Regulation number
- 866.3830
- GUDID distribution status
- In Commercial Distribution
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