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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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IMMAGE - 15099590221225

IMMAGE Immunochemistry Systems IGALC Low Concentration ImmunoglobuIin A
Beckman Coulter, Inc.
447460
In Commercial Distribution

  • 15099590221225 ()
447460

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

IMMAGE - 15099590221218

IMMAGE Immunochemistry Systems IGMLC Low Concentration ImmunoglobuIin M
Beckman Coulter, Inc.
447470
In Commercial Distribution

  • 15099590221218 ()
447470

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

IMMAGE - 15099590221195

IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent
Beckman Coulter, Inc.
447610
In Commercial Distribution

  • 15099590221195 ()
447610

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

AU - 15099590011598

IgM
Beckman Coulter, Inc.
OSR61173
In Commercial Distribution

  • 15099590011598 ()


  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

AU - 15099590011574

IgA
Beckman Coulter, Inc.
OSR61171
In Commercial Distribution

  • 15099590011574 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

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
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