Diamedix 720-700

• FDA 510(k) K994424 decided 18 Feb 2000 Active
• FDA GUDID UDI-DI 00817273020372 listed 20 Sep 2016 Listed

1. 18 Feb 2000 Cleared FDA 510(k) K994424
2. 20 Sep 2016 Listed FDA GUDID 00817273020372

Trade name

Diamedix

Generic name

Nucleic acid hybridization detection IVD, kit

Model / reference

720-700

Description

"720-700 anti-dsDNA Test Kit"

Primary DI / UDI-DI

00817273020372

510(k) Number

K994424 ↗

FDA product code

LRM

GMDN term

Nucleic acid hybridization detection IVD, kit

Device class

Class II

Regulation number

866.5100

GUDID distribution status

In Commercial Distribution

Category: Nucleic acid hybridization detection IVD, kit

Other devices filed under FDA product code LRM (Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control).

• ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT by Helix Diagnostics, Inc.
• IMMULISA DSDNA ANTIBODY ELISA by Immco Diagnostics, Inc.
• HYTEC AUTOMIMMUNE KIT (DS-DNA) by HYCOR BIOMEDICAL LLC
• BINDAZYME ANTI-DSDNA EIA KIT by The Binding Site, Ltd.
• THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET by ZEUS SCIENTIFIC, INC.
• NDNA ANTIBODY TEST KIT by Lipogen, Inc.
• ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY by American Laboratory Products Company
• VARELISA COMBINED DNA ANTIBODIES EIA by Elias U.S.A., Inc.
• MDI DS-DNA TEST by Micro Detect, Inc.
• DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM by MARDX DIAGNOSTICS, 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. →