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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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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
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
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
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
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
Sample Diluent/Wash Powder , 5g
MARDX DIAGNOSTICS, INC.
40-2030
In Commercial Distribution

  • 05391516749152 ()
40-2030

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
T. pallidum Marblot Strip, 20 each pack
MARDX DIAGNOSTICS, INC.
40-5018
In Commercial Distribution

  • 05391516749114 ()
40-5018

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
FITC Parasite IgG Conjugate (Rodent), 4.0 mL
MARDX DIAGNOSTICS, INC.
20-90215
In Commercial Distribution

  • 05391516748872 ()
20-90215

  • Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, reagent
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
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