Diamedix 720-640
Diamedix 720-640 is a Class I device made by Diamedix Corp., cleared under FDA 510(k) K981831 on 16 Feb 1999 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00817273020358), active as of 22 Oct 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00817273020358 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK981831 | Date16 Feb 1999 | StatusActive |
Official records
- AccessGUDID record 00817273020358
- FDA 510(k) database K981831
Across registries
- FDA 510(k) K981831 decided 16 Feb 1999 Active
- FDA GUDID UDI-DI 00817273020358 listed 20 Sep 2016 Listed
Recalls
-
- Terminated Z-2574-2018
Contains a gel-like contaminant that may affect product performance.
-
- Terminated Z-1687-2016
A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
Timeline
- Cleared FDA 510(k) K981831
- Recall initiated FDA recalls Z-1687-2016
- Listed FDA GUDID 00817273020358
- Recall initiated FDA recalls Z-2574-2018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Diamedix
- Generic name
- Echinococcus granulosus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
- Model / reference
- 720-640
- Description
- "720-640 EBV-EA-D IgG Test Kit"
- Primary DI / UDI-DI
- 00817273020358
- 510(k) Number
- FDA product code
- GNP
- GMDN term
- Echinococcus granulosus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class I
- Regulation number
- 866.3235
- GUDID distribution status
- In Commercial Distribution
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