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Diamedix 720-620

by Diamedix Corp.

Diamedix 720-620 is a Class I device made by Diamedix Corp., cleared under FDA 510(k) K981812 on 4 Mar 1999 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00817273020334), active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K981812

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817273020334 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK981812 Date4 Mar 1999DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K981812 decided 4 Mar 1999 Active
  • FDA GUDID UDI-DI 00817273020334 listed 20 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1686-2016 FDA Class II initiated 20 Oct 2014

    A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.

Timeline

3 dated events

  1. Cleared FDA 510(k) K981812
  2. Recall initiated FDA recalls Z-1686-2016
  3. Listed FDA GUDID 00817273020334

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Diamedix
Generic name
Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot
Model / reference
720-620
Description
"720-620 EBNA-1 IgG Test Kit"
Primary DI / UDI-DI
00817273020334
510(k) Number
FDA product code
LSE
GMDN term
Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot
Device class
Class I
Regulation number
866.3235
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot

Cleared under the same submission (K981812)

Similar devices

Other devices filed under FDA product code LSE (Epstein-Barr Virus, Other).

Other devices from Diamedix Corp.

See all devices from Diamedix Corp. →

Properties

  • Convenience kit
  • Lot / batch number
Other properties (13, all answered No)