Diamedix 720-420
Diamedix 720-420 is a Class II device made by Diamedix Corp., cleared under FDA 510(k) K012449 on 26 Oct 2001 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00817273020235), 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 | Number00817273020235 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK012449 | Date26 Oct 2001 | StatusActive |
Official records
- AccessGUDID record 00817273020235
- FDA 510(k) database K012449
Across registries
- FDA 510(k) K012449 decided 26 Oct 2001 Active
- FDA GUDID UDI-DI 00817273020235 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K012449
- Listed FDA GUDID 00817273020235
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Diamedix
- Generic name
- Cryptosporidium parvum immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
- Model / reference
- 720-420
- Description
- "720-420 anti-Cardiolipin IgATest Kit"
- Primary DI / UDI-DI
- 00817273020235
- 510(k) Number
- FDA product code
- MID
- GMDN term
- Cryptosporidium parvum immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class II
- Regulation number
- 866.5660
- GUDID distribution status
- In Commercial Distribution
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Other devices filed under FDA product code MID (System, Test, Anticardiolipin Immunological).
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- EL-ACL SCREEN; EL-ACL IGM, IGG, IGA by THERATEST LABORATORIES, INC.
- ELIAS CARDIOLIPIN IGG ANTIBODIES by Elias U.S.A., Inc.
- VARELISA CARDIOLIPIN ABS SCREEN by Elias U.S.A., Inc.
- CARDIOLIPIN IGG, M, A EIA TEST SYSTEM by Immunoprobe, Inc.