Diamedix 720-370
Diamedix 720-370 is a Class II device made by Diamedix Corp., cleared under FDA 510(k) K001875 on 21 Aug 2000 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00817273020204), active as of 22 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 | Number00817273020204 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK001875 | Date21 Aug 2000 | StatusActive |
Official records
- AccessGUDID record 00817273020204
- FDA 510(k) database K001875
Across registries
- FDA 510(k) K001875 decided 21 Aug 2000 Active
- FDA GUDID UDI-DI 00817273020204 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K001875
- Listed FDA GUDID 00817273020204
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Diamedix
- Generic name
- Rubella virus immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
- Model / reference
- 720-370
- Description
- "720-370 Rubella IgM Test Kit"
- Primary DI / UDI-DI
- 00817273020204
- 510(k) Number
- FDA product code
- LFX
- GMDN term
- Rubella virus immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
- Device class
- Class II
- Regulation number
- 866.3510
- GUDID distribution status
- In Commercial Distribution