Diamedix 720-380

• FDA 510(k) K001875 decided 21 Aug 2000 Active
• FDA GUDID UDI-DI 00817273020211 listed 20 Sep 2016 Listed

1. 21 Aug 2000 Cleared FDA 510(k) K001875
2. 20 Sep 2016 Listed FDA GUDID 00817273020211

Trade name

Diamedix

Generic name

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

Model / reference

720-380

Description

"720-380 VZV IgG Test Kit"

Primary DI / UDI-DI

00817273020211

510(k) Number

K001875 ↗

FDA product code

LFX

GMDN term

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

Device class

Class II

Regulation number

866.3510

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 LFX (Enzyme Linked Immunoabsorbent Assay, Rubella).

• IMMULITE® Systems RUM CONTROL Rubella IgM 10469597 LRMCM by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
• MODIFICATION OF SEROCARD RUBELLA IGG TEST by Disease Detection International, Inc.
• Atellica IM Rub M QC 10995669 by Siemens Healthcare Diagnostics Inc.
• FIAGEN RUBELLA IGG by Cyberfluor, Inc.
• ORTHO RUBELLA ELISA TEST SYSTEM by Ortho Diagnostic Systems, Inc.
• IMMULITE® 2000 Systems RUB Rubella Quantitative IgG 10381338 L2KRUB2 by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
• RUBELLA IGG ELISA TEST by Gull Laboratories, Inc.
• BARTELS RUBELLA IGM EIA by Baxter Diagnostics, Inc.
• ELECSYS RUBELLA IGM IMMUNOASSAY by Roche Diagnostics Corp.
• ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY by Abbott Laboratories

• 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

• Diamedix 720-650

  Class I

  FDA 510(k) K982350 Active Cleared 25 Nov 1998 GUDID on market

See all devices from Diamedix Corp. →