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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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AccuDiag ™Herpes Simplex 2 IgG (HSV 2 IgG) ELISA
Diagnostic Automation, Inc.
DACD1403-2
In Commercial Distribution

  • 00850054026088 ()

  • 96 Tests
1403-2

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QMedix™Toxoplasma Gondii IgG ELISA Kit This test is intended for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the parasitic protozoan Toxoplasma gondii in a clinical specimen, using an enzyme immunoassay (EIA) method.
Diagnostic Automation, Inc.
DACD1101-1
In Commercial Distribution

  • 00850054026002 ()

  • 96 tests
1101-1

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
TG Ab Sample Diluent - IMMULITE - CAL - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387073
In Commercial Distribution

  • 00630414954318 ()
L2TYZ

  • Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, control
Folic/B12 Common Sample - IMMULITE - CONS - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387054
In Commercial Distribution

  • 00630414954455 ()
L2FVZ

  • Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, control
Toxoplasma IgG EIA
Bio-RAD Laboratories, Inc.
25175
In Commercial Distribution

  • 00847865010702 ()

  • 96 Tests
25175

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
HSV-1 IgG Calibrator
Abbott Ireland Diagnostics
04W2002
In Commercial Distribution

  • 00380740213879 ()
04W2002

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, calibrator
Alinity i Toxo IgG Calibrators
Abbott GmbH
07P4504
In Commercial Distribution

  • 00380740203177 ()
07P4504

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, calibrator
VIDAS ® TOXO IgG Avidity assay is a qualitative IA intended for use on VIDAS family instrument for the determination of anti - toxoplasma IgG avidity in human serum.
BIOMERIEUX SA
30222-01
In Commercial Distribution

  • 03573026263010 ()


  • Toxoplasma gondii immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)
TOXO IgG II (TXG) assay is a quantitative IA intended for use on VIDAS family instrument in the detection of anti - toxoplasma IgG concentration in human serum or plasma.
BIOMERIEUX SA
30210-01
In Commercial Distribution

  • 03573026156855 ()


  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Reagent Red Blood Cells (Pooled Cells) Ortho® Coombs Control
ORTHO-CLINICAL DIAGNOSTICS, INC.
719810
In Commercial Distribution

  • 10758750004072 ()
719810

  • Immunoglobulin-sensitized reagent red blood cell IVD, control
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