Sofia 20319
by Quidel Corp.
Sofia 20319 is a Class II device made by Quidel Corp., cleared under FDA 510(k) K173496 on 30 Aug 2018 and listed in FDA GUDID since 10 Dec 2019 (UDI-DI 30014613337799), 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 | Number30014613337799 | Date10 Dec 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK173496 | Date30 Aug 2018 | StatusActive |
Official records
- AccessGUDID record 30014613337799
- FDA 510(k) database K173496
Across registries
- FDA 510(k) K173496 decided 30 Aug 2018 Active
- FDA GUDID UDI-DI 30014613337799 listed 10 Dec 2019 Listed
Timeline
- Cleared FDA 510(k) K173496
- Listed FDA GUDID 30014613337799
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sofia
- Generic name
- Borrelia burgdorferi total antibody IVD, kit, fluorescent immunoassay
- Model / Ref / Catalog
- 20319
- Primary DI / UDI-DI
- 30014613337799
- 510(k) Number
- 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
Similar devices
Other devices filed under FDA product code LSR (REAGENT, BORRELIA SEROLOGICAL REAGENT).
- LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus by Diasorin Inc.
- BORRELIA BURGDORFERI IGM BLOT TEST by Gold Standard Diagnostics, LLC
- APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM by ZEUS SCIENTIFIC, INC.
- HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES by Cambridge Bioscience Corp.
- Viramed Borrela All-In-One ViraChip Test Kit by Viramed Biotech AG
- iDart Lyme IgM ImmunoBlot Kit by Id-Fish Technology, Inc.
- BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG by Boston Biomedica, Inc.
- Borrelia B31 ViraChip IgG Test Kit by Viramed Biotech AG
- LYME STAT TEST KIT by Whittaker Bioproducts, Inc.
- CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112) by Cambridge Biotech Corp.