Diamedix 300-312A

• FDA 510(k) K001767 decided 7 Aug 2000 Active
• FDA GUDID UDI-DI 00817273020020 listed 20 Sep 2016 Listed

1. 7 Aug 2000 Cleared FDA 510(k) K001767
2. 20 Sep 2016 Listed FDA GUDID 00817273020020

Trade name

Diamedix

Generic name

Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

Model / reference

300-312A

Description

"300-312A Toxoplasma IgM Capture Lyoph. Ag. Accessory Kit"

Primary DI / UDI-DI

00817273020020

510(k) Number

K001767 ↗

FDA product code

LJO

GMDN term

Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

Device class

Class II

Regulation number

866.3175

GUDID distribution status

In Commercial Distribution

Category: Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

Other devices filed under FDA product code LJO (Antigen, Iha, Cytomegalovirus).

• CETUS CMV IHA by Cetus Corp.
• Capture-CMV by IMMUCOR, INC.
• Cytomegalovirus Antibody Screen by IMMUCOR, INC.
• Alliance Cytomegalovirus Immediate Early Antigen Direct Immunofluorescence Assay by E.I. Dupont DE Nemours & Co., Inc.
• HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS by Akers Research Corp.
• CMV-IHA by Hillcrest Biologicals
• HYBRID CAPTURE SYSTEM CMV DNA ASSAY by Digene Corp.
• CMVGEN by INSTRUMENTATION LABORATORY COMPANY
• COPALIS CMV TOTAL ANTIBODY ASSAY by Sienna Biotech, Inc.
• CMV LATEX AGGLUTINATION TEST KIT by Bd Becton Dickinson Vacutainer Systems Preanalytic

• 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. →