Diamedix 720-440

• FDA 510(k) K983390 decided 18 Nov 1998 Active
• FDA GUDID UDI-DI 00817273020259 listed 20 Sep 2016 Listed

1. 18 Nov 1998 Cleared FDA 510(k) K983390
2. 20 Sep 2016 Listed FDA GUDID 00817273020259

Trade name

Diamedix

Generic name

Echinococcus multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Model / reference

720-440

Description

"720-440 anti-PR-3 (C-ANCA) IgG Test Kit"

Primary DI / UDI-DI

00817273020259

510(k) Number

K983390 ↗

FDA product code

MOB

GMDN term

Echinococcus multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Device class

Class II

Regulation number

866.5660

GUDID distribution status

In Commercial Distribution

Category: Echinococcus multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Other devices filed under FDA product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)).

• IFA: Granulocyte Mosaic 13 EUROPattern FC 1201-1010-13 by EUROIMMUN Medizinische Labordiagnostika AG
• EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay by Phadia AB
• ORGENTEC ANTI-MPO (P-ANCA) ELISA by American Laboratory Products Company
• VARELISA MPO-ANCA by Elias U.S.A., Inc.
• VIRGO ANCA SCREEN KIT by HEMAGEN DIAGNOSTICS, INC.
• PROTEINASE-3 IGG ELISA TEST SYSTEM by ZEUS SCIENTIFIC, INC.
• IFA: Granulocyte Mosaic 2 FA 1201-1005-2 by EUROIMMUN Medizinische Labordiagnostika AG
• Alegria Flash MPO by ZEUS SCIENTIFIC, INC.
• AESKULISA® MPO 3303 by Aesku.Diagnostics GmbH & Co. KG
• SCIMEDX PHASE II PR3 IGG ANTIBODY EIA by Scimedx Corp.

• 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. →