Diamedix 720-400
Diamedix 720-400 is a Class II device made by Diamedix Corp., cleared under FDA 510(k) K981867 on 28 Sep 1998 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00817273020228), 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 | Number00817273020228 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK981867 | Date28 Sep 1998 | StatusActive |
Official records
- AccessGUDID record 00817273020228
- FDA 510(k) database K981867
Across registries
- FDA 510(k) K981867 decided 28 Sep 1998 Active
- FDA GUDID UDI-DI 00817273020228 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K981867
- Listed FDA GUDID 00817273020228
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Diamedix
- Generic name
- Measles virus immunoglobulin G (IgG) antibody IVD, kit, complement fixation test (CFT)
- Model / reference
- 720-400
- Description
- "720-400 anti-Cardiolipin IgG/IgM Test Kit"
- Primary DI / UDI-DI
- 00817273020228
- 510(k) Number
- FDA product code
- LFY
- GMDN term
- Measles virus immunoglobulin G (IgG) antibody IVD, kit, complement fixation test (CFT)
- Device class
- Class II
- Regulation number
- 866.3900
- GUDID distribution status
- In Commercial Distribution
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