Diamedix 720-300

• FDA 510(k) K981498 decided 21 Aug 1998 Active
• FDA GUDID UDI-DI 00817273020136 listed 20 Sep 2016 Listed

1. 21 Aug 1998 Cleared FDA 510(k) K981498
2. 20 Sep 2016 Listed FDA GUDID 00817273020136

Trade name

Diamedix

Generic name

Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Model / reference

720-300

Description

"720-300 Toxoplasma IgG Test Kit"

Primary DI / UDI-DI

00817273020136

510(k) Number

K981498 ↗

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

Category: Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Other devices filed under FDA product code LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii).

• Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl by Roche Diagnostics Corp.
• AMIZYME-TOXOPLASMA GONDII KIT by Amico Lab, Inc.
• CAPTIA TOXO-G by Mercia Diagnostics, Ltd.
• MODIFIED TOXOPLASMA GONDII IGG EIA TEST KIT by Labsystems, Inc.
• OPUS(R) ROZO by Pb Diagnostic Systems, Inc.
• BARTELS TOXOPLASMA IGG EIA by Baxter Diagnostics, Inc.
• VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210 by BIOMERIEUX, INC.
• DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS by Diasorin S.P.A
• CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY by Cytotech, Inc.
• TOXO IGM ELISA TEST by Gull Laboratories, Inc.

• 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. →