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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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The ImmunoFA Toxo IgM Test is an immunofluorescence test for the presumptive detection and titration of IgM antibodies to Toxoplasma gondii in human serum and is presumptive for the diagnosis of acute, recent, or reactivated T. gondii infection. It is intended that the ImmunoFA Toxo IgG Test be performed in conjunction with this assay. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.
Genbio
800-1300
In Commercial Distribution

  • 00613745013008 ()

  • 100 tests
1300

  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
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
Positive control for use with ImmunoFA Toxoplasma IgG kit.
Genbio
800-1205
In Commercial Distribution

  • 00613745012056 ()

  • 1.0 mL
1205

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control
Positive Control for use with ImmunoFA Toxoplasma IgG kit.
Genbio
800-1204
In Commercial Distribution

  • 00613745012049 ()

  • 1.0 mL
1204

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control
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
IgG conjugate for use with ImmunoFA Toxoplasma IgG kit.
Genbio
800-1202
In Commercial Distribution

  • 00613745012025 ()

  • 3.5 mL
1202

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, reagent
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
The ImmunoFA Toxo IgG Test is an immunofluorescence test for the detection and titration of IgG antibodies to Toxoplasma gondii in human serum. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.
Genbio
800-1200
In Commercial Distribution

  • 00613745012001 ()

  • 100 tests
1200

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
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
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
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