Diamedix 720-520
Diamedix 720-520 is a Class II device made by Diamedix Corp., cleared under FDA 510(k) K012053 on 20 Aug 2001 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00817273020297), 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 | Number00817273020297 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK012053 | Date20 Aug 2001 | StatusActive |
Official records
- AccessGUDID record 00817273020297
- FDA 510(k) database K012053
Across registries
- FDA 510(k) K012053 decided 20 Aug 2001 Active
- FDA GUDID UDI-DI 00817273020297 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K012053
- Listed FDA GUDID 00817273020297
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- Withdrawn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
- 720-520
- Description
- "720-520 Measles IgG Test Kit"
- Primary DI / UDI-DI
- 00817273020297
- 510(k) Number
- FDA product code
- MID
- GMDN term
- Measles virus immunoglobulin G (IgG) antibody IVD, kit, complement fixation test (CFT)
- Device class
- Class II
- Regulation number
- 866.5660
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code MID (System, Test, Anticardiolipin Immunological).
- HEMAGEN ACL IGA CALIBRATOR by HEMAGEN DIAGNOSTICS, INC.
- THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F by ZEUS SCIENTIFIC, INC.
- AESKULISA CARDIOLIPIN AGM by Aesku, Inc.
- REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001 by Corgenix, Inc.
- QACA IGG/IGM ELISA KIT HRP by Cheshire Diagnostics, Ltd.
- ANTI-CARDIOLIPIN ANTIBODY (IGM-ACA) TEST by Immco Diagnostics, Inc.
- VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596 by Pharmacia Deutschland GmbH
- IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST by General Biometrics, Inc.
- BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT by The Binding Site, Ltd.
- REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139 by Corgenix, Inc.