Bio-Rad Laboratories 25189
Bio-Rad Laboratories 25189 is a Class I device made by Bio-Rad Laboratories, cleared under FDA 510(k) K033915 on 16 Jan 2004 and listed in FDA GUDID since 22 Jan 2023 (UDI-DI 00847865011167), 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 | Number00847865011167 | Date22 Jan 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK033915 | Date16 Jan 2004 | StatusActive |
Official records
- AccessGUDID record 00847865011167
- FDA 510(k) database K033915
Across registries
- FDA 510(k) K033915 decided 16 Jan 2004 Active
- FDA GUDID UDI-DI 00847865011167 listed 22 Jan 2023 Listed
Timeline
- Cleared FDA 510(k) K033915
- Listed FDA GUDID 00847865011167
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bio-Rad Laboratories
- Generic name
- Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
- Model / Ref / Catalog
- 25189
- Primary DI / UDI-DI
- 00847865011167
- 510(k) Number
- FDA product code
- LSE
- GMDN term
- Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class I
- Regulation number
- 866.3235
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 25 Milliliter
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Other devices filed under FDA product code LSE (EPSTEIN-BARR VIRUS, OTHER).
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