Diamedix 720-350
Diamedix 720-350 is a Class II device made by Diamedix Corp., cleared under FDA 510(k) K002262 on 28 Nov 2000 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00817273020181), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00817273020181 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK002262 | Date28 Nov 2000 | StatusActive |
Official records
- AccessGUDID record 00817273020181
- FDA 510(k) database K002262
Across registries
- FDA 510(k) K002262 decided 28 Nov 2000 Active
- FDA GUDID UDI-DI 00817273020181 listed 20 Sep 2016 Listed
Recalls
-
- Terminated Z-1520-2012
On 01/16/20112 Diamedix initiated a recall of IS-HSV 1&2 IgM Test Kit, Catalog # 720-350, Lot 60701, Exp. June 30, 2012. The Positive Control for this lot is Out of Specification.
Timeline
- Cleared FDA 510(k) K002262
- Recall initiated FDA recalls Z-1520-2012
- Listed FDA GUDID 00817273020181
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Diamedix
- Generic name
- Multiple Candida species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)
- Model / reference
- 720-350
- Description
- "720-350 HSV 1&2 IgM Test Kit"
- Primary DI / UDI-DI
- 00817273020181
- 510(k) Number
- FDA product code
- LCG
- GMDN term
- Multiple Candida species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class II
- Regulation number
- 876.5980
- GUDID distribution status
- In Commercial Distribution