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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Trinity Biotech - 05391516748704

T. Pallidum IgG Marblot Strip Test System, Western Blot System for the detection of IgG antibody to T. pallidum, 20 Tests
MARDX DIAGNOSTICS, INC.
40-5020G
In Commercial Distribution

  • 05391516748704 ()
40-5020G

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

ImmunoFA Toxoplasma Slides - 00613745012070

For use with ImmunoFA Toxoplasma kits
Genbio
800-1207
In Commercial Distribution

  • 00613745012070 ()

  • 100 slides, 10 tests per slide
1207

  • Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, reagent

ImmunoFA Toxoplasma IgG Negative Control - 00613745012032

Negative control for use with ImmunoFA Toxoplasma kits.
Genbio
800-1203
In Commercial Distribution

  • 00613745012032 ()

  • 1.0 mL
1203

  • Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, reagent

ImmunoFA Toxoplasma Slides - 00613745012018

Toxoplasma Slides for use with ImmunoFA Toxoplasma kits
Genbio
800-1201
In Commercial Distribution

  • 00613745012018 ()

  • 10 slides, 10 tests each slide
1201

  • Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, reagent

ImmunoFA Mounting Fluid - 00613745010250

Mounting fluid for use with ImmunoFA kits.
Genbio
800-1025
In Commercial Distribution

  • 00613745010250 ()

  • 5 mL
1025

  • Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, reagent

ImmunoFA 10x PBS - 00613745010069

10-fold concentrate of 0.01M PBS
Genbio
800-1006
In Commercial Distribution

  • 00613745010069 ()

  • 250 mL
1006

  • Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, reagent

ImmunoFA 10x PBS - 00613745010052

10-fold concentrate of 0.01M PBS
Genbio
800-1005
In Commercial Distribution

  • 00613745010052 ()

  • 50 mL
1005

  • Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, reagent

AtheNA Multi-Lyte® T. pallidum IgG Plus Test System - 00845533000116

The ZEUS AtheNA Multi-Lyte® Treponema pallidum IgG Plus Test System is a multiplex flow immunoassay intended for the qualitative detection of specific human IgG class antibodies to Treponema pallidum in human sera. The presence of antibodies to T. pallidum specific antigen, in conjunction with non treponemal laboratory tests and clinical findings, may aid in the diagnosis of syphilis infection. This test is for In Vitro diagnostic use only. This test is not intended for screening blood or plasma donors.
ZEUS SCIENTIFIC, INC.
A76101G
In Commercial Distribution

  • 00845533000116 ()
A76101G

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865010924

Syphilis IgG Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_v1
In Commercial Distribution

  • 00847865010924 ()

  • 1 Each
6651470E

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865006682

Manual & CDs, Syphilis IgG IFU, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_V1
In Commercial Distribution

  • 00847865006682 ()

  • 1 Each
6651460F

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
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