Diamedix 720-710

• FDA 510(k) K021394 decided 9 Jul 2002 Active
• FDA GUDID UDI-DI 00817273020389 listed 20 Sep 2016 Listed

1. 9 Jul 2002 Cleared FDA 510(k) K021394
2. 20 Sep 2016 Listed FDA GUDID 00817273020389

Trade name

Diamedix

Generic name

Multiple rheumatoid arthritis-associated antibody IVD, kit, multiplex

Model / reference

720-710

Description

"720-710 Rheumatoid Factor Test Kit"

Primary DI / UDI-DI

00817273020389

510(k) Number

K021394 ↗

FDA product code

DHR

GMDN term

Multiple rheumatoid arthritis-associated antibody IVD, kit, multiplex

Device class

Class II

Regulation number

866.5775

GUDID distribution status

In Commercial Distribution

Category: Multiple rheumatoid arthritis-associated antibody IVD, kit, multiplex

Other devices filed under FDA product code DHR (System, Test, Rheumatoid Factor).

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• EliA RF IgM Immunoassay by Phadia AB
• LASER RF CONTROL SERUM-QUALITY CONTROL SERUM by Behring Diagnostics, Inc.
• ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA by Immco Diagnostics, Inc.
• COLOR-SLIDE RF by Seradyn, Inc.
• RF CARD TEST by Preco, Inc.
• TINAQUANT RHEUMATOID FACTOR ASSAY by Boehringer Mannheim Corp.
• ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST by J.S. Medical Assoc.
• TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM by Unipath, Ltd.
• K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET by KAMIYA BIOMEDICAL COMPANY, LLC

• 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. →