Diamedix 720-340

• FDA 510(k) K981306 decided 29 Sep 1998 Active
• FDA GUDID UDI-DI 00817273020174 listed 20 Sep 2016 Listed

1. 29 Sep 1998 Cleared FDA 510(k) K981306
2. 20 Sep 2016 Listed FDA GUDID 00817273020174

Trade name

Diamedix

Generic name

Measles virus immunoglobulin G (IgG) antibody IVD, kit, complement fixation test (CFT)

Model / reference

720-340

Description

"720-340 HSV 1&2 IgG Test Kit"

Primary DI / UDI-DI

00817273020174

510(k) Number

K981306 ↗

FDA product code

LGC

GMDN term

Measles virus immunoglobulin G (IgG) antibody IVD, kit, complement fixation test (CFT)

Device class

Class II

Regulation number

866.3305

GUDID distribution status

In Commercial Distribution

Category: Measles virus immunoglobulin G (IgG) antibody IVD, kit, complement fixation test (CFT)

Other devices filed under FDA product code LGC (Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific).

• IMMULITE HERPES I AND II IGG by Diagnostic Products Corp.
• IDEIA Herpes Simplex Virus Test by Boots-Celltech Diagnostics, Inc.
• HSV 1+2 IGG ELISA TEST by Gull Laboratories, Inc.
• KODAK SURECELL HERPES (HSV) TEST KIT by EASTMAN KODAK COMPANY
• HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM by ZEUS SCIENTIFIC, INC.
• ADVIA Centaur Herpes-2 IgG 10720849 by Siemens Healthcare Diagnostics Inc.
• PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST by Meridian Diagnostics, Inc.
• HSV-2 IGM ELISA TEST by Gull Laboratories, Inc.
• BARTELS HERPES SIMPLEX VIRUS 1 IGM EIA by Baxter Diagnostics, Inc.
• THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR by ZEUS SCIENTIFIC, 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. →