Diamedix 720-360
Diamedix 720-360 is a Class II device made by Diamedix Corp., cleared under FDA 510(k) K981729 on 28 Jan 1999 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00817273020198), 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 | Number00817273020198 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK981729 | Date28 Jan 1999 | StatusActive |
Official records
- AccessGUDID record 00817273020198
- FDA 510(k) database K981729
Across registries
- FDA 510(k) K981729 decided 28 Jan 1999 Active
- FDA GUDID UDI-DI 00817273020198 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K981729
- Listed FDA GUDID 00817273020198
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- Withdrawn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
- 720-360
- Description
- "720-360 Rubella IgG Test Kit"
- Primary DI / UDI-DI
- 00817273020198
- 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