Diamedix 300-331A
Diamedix 300-331A is a Class I device made by Diamedix Corp., cleared under FDA 510(k) K990462 on 3 Sep 1999 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00817273020037), 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 | Number00817273020037 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK990462 | Date3 Sep 1999 | StatusActive |
Official records
- AccessGUDID record 00817273020037
- FDA 510(k) database K990462
Across registries
- FDA 510(k) K990462 decided 3 Sep 1999 Active
- FDA GUDID UDI-DI 00817273020037 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K990462
- Listed FDA GUDID 00817273020037
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Diamedix
- Generic name
- Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
- Model / reference
- 300-331A
- Description
- 300-331A CMV IgM Capture Lyoph. Ag. Accessory Kit
- Primary DI / UDI-DI
- 00817273020037
- 510(k) Number
- FDA product code
- LYR
- GMDN term
- Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
- Device class
- Class I
- Regulation number
- 866.3110
- GUDID distribution status
- In Commercial Distribution