Autoimmune EIA 425-2420
Autoimmune EIA 425-2420 (4252420) is a Class II device made by Bio-Rad Laboratories, cleared under FDA 510(k) K091859 on 3 Jun 2010 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00847817018695), 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 | Number00847817018695 | Date12 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK091859 | Date3 Jun 2010 | StatusActive |
Official records
- AccessGUDID record 00847817018695
- FDA 510(k) database K091859
Across registries
- FDA 510(k) K091859 decided 3 Jun 2010 Active
- FDA GUDID UDI-DI 00847817018695 listed 12 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K091859
- Listed FDA GUDID 00847817018695
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Autoimmune EIA
- Generic name
- Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA)
- Model / Ref / Catalog
- 425-2420, 4252420
- Primary DI / UDI-DI
- 00847817018695
- 510(k) Number
- FDA product code
- MOB
- GMDN term
- Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class II
- Regulation number
- 866.5660
- GUDID distribution status
- In Commercial Distribution
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