Diamedix 720-480

• FDA 510(k) K983553 decided 7 Dec 1998 Active
• FDA GUDID UDI-DI 00817273020280 listed 20 Sep 2016 Listed

1. 7 Dec 1998 Cleared FDA 510(k) K983553
2. 20 Sep 2016 Listed FDA GUDID 00817273020280

Trade name

Diamedix

Generic name

Anti-E [RH0003] antibody screen IVD, control

Model / reference

720-480

Description

"720-480 anti-Cardiolipin Screen"

Primary DI / UDI-DI

00817273020280

510(k) Number

K983553 ↗

FDA product code

JZO

GMDN term

Anti-E [RH0003] antibody screen IVD, control

Device class

Class II

Regulation number

866.5870

GUDID distribution status

In Commercial Distribution

Category: Anti-E [RH0003] antibody screen IVD, control

Other devices filed under FDA product code JZO (System, Test, Thyroid Autoantibody).

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• Nova Lite Thyroid by Inova Diagnostics. Inc.
• EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 by Phadia AB
• ELIAS TMAB by Elias U.S.A., Inc.
• 125-I TSH Receptor Antibody Kit by Cronus
• Orgentec Anti-Tpo Pia by American Laboratory Products Company
• Milenia Anti-Tg EIA by American Laboratory Products Company
• Brahms Diagnostica DYNOTEST Anti-TPO by Brahms Diagnostica, LLC
• Thyretain TSI Reporter Bioassay by DIAGNOSTIC HYBRIDS, INC.
• FIDIS TM THYRO, MODEL MX002 by Biomedical Diagnostics (Bmd) SA

• Diamedix 720-380

  Class II

  FDA 510(k) K001875 Active Cleared 21 Aug 2000 GUDID on market

• Diamedix 789-008

  Class I

  GUDID on market

• Diamedix 720-250

  Class II

  FDA 510(k) K970218 Active Cleared 8 Apr 1997 GUDID on market

• Diamedix 720-540

  Class I

  FDA 510(k) K974552 Active Cleared 28 Jan 1998 GUDID on market

See all devices from Diamedix Corp. →