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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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ANTI-SARS-CoV-2 IgG ANTIBODY ELISA TEST KIT, 96 TESTS
THERA-TEST LABORATORIES, INC
104-130
Not in Commercial Distribution

  • 00854473003330 ()
104-130

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
100 test kit
FUJIREBIO DIAGNOSTICS, INC.
1626
In Commercial Distribution

  • 00850212007010 ()

  • Size Type = Tests per Kit; Size Unit = 100; Unit of Measure = Tests


  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination
220 test kit
FUJIREBIO DIAGNOSTICS, INC.
1633
In Commercial Distribution

  • 00850212007027 ()

  • Size Type = Tests per Kit; Size Unit = 220; Unit of Measure = Tests


  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination
The DRG Echinococcus IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Echinococcus in human serum and plasma (EDTA-, heparin- or citrate plasma).
DRG International Inc
EIA-3472
In Commercial Distribution

  • 00840239034724 ()
EIA-3472

  • Echinococcus granulosus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Coxiella burnetii (Q-Fever) Phase 2 in human serum or plasma (citrate, heparin).
DRG International Inc
EIA-5189
In Commercial Distribution

  • 00840239051899 ()
EIA-5189

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Coxiella burnetii (Q-Fever) Phase 1 in human serum or plasma (citrate, heparin).
DRG International Inc
EIA-5188
In Commercial Distribution

  • 00840239051882 ()
EIA-5188

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Calibrator
ORTHO CLINICAL DIAGNOSTICS
6199961
In Commercial Distribution

  • 10758750034420 ()
6199961

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6199960
In Commercial Distribution

  • 10758750034413 ()
6199960

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6199951
In Commercial Distribution

  • 20758750033604 ()
  • 10758750033607 ()
6199951

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
AccuDiag™ Echinococcus IgG ELISA
Diagnostic Automation, Inc.
DACD8202-35
In Commercial Distribution

  • 00894175000138 ()

  • 96 Tests
8202-35

  • Echinococcus granulosus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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