Diamedix 720-650

• FDA 510(k) K982350 decided 25 Nov 1998 Active
• FDA GUDID UDI-DI 00817273020365 listed 20 Sep 2016 Listed

1. 25 Nov 1998 Cleared FDA 510(k) K982350
2. 20 Sep 2016 Listed FDA GUDID 00817273020365

Trade name

Diamedix

Generic name

Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot

Model / reference

720-650

Description

"720-650 EBV-EA-D IgM Test Kit"

Primary DI / UDI-DI

00817273020365

510(k) Number

K982350 ↗

FDA product code

LSE

GMDN term

Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot

Device class

Class I

Regulation number

866.3235

GUDID distribution status

In Commercial Distribution

Category: Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot

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• BIOTEST ANTI-EBV RECOMBINANT by Biotest Diagnostics Corp.
• EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA by Incstar Corp.
• EBV-EA TEST by Gull Laboratories, Inc.
• THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO by ZEUS SCIENTIFIC, INC.
• Trinity Biotech 2325761 by CLARK LABORATORIES, INC.
• IMMUNODOT MONO-M TEST by Genbio
• INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KIT by Incstar 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. →