Diamedix 720-310
Diamedix 720-310 is a Class II device made by Diamedix Corp., cleared under FDA 510(k) K001707 on 7 Jul 2000 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00817273020143), 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 | Number00817273020143 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK001707 | Date7 Jul 2000 | StatusActive |
Official records
- AccessGUDID record 00817273020143
- FDA 510(k) database K001707
Across registries
- FDA 510(k) K001707 decided 7 Jul 2000 Active
- FDA GUDID UDI-DI 00817273020143 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K001707
- Listed FDA GUDID 00817273020143
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Diamedix
- Generic name
- Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
- Model / reference
- 720-310
- Description
- "720-310 Toxoplasma IgM Test Kit"
- Primary DI / UDI-DI
- 00817273020143
- 510(k) Number
- FDA product code
- LGD
- GMDN term
- Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
- Device class
- Class II
- Regulation number
- 866.3780
- GUDID distribution status
- In Commercial Distribution
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Other devices filed under FDA product code LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii).
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- TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560 by Clinical Sciences, Inc.
- Atellica IM Toxo G QC 10995700 by Siemens Healthcare Diagnostics Inc.
- TREND(R) EMERGE(TM) TOXOPLASMA IGG ELISA by Lmd Laboratories