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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 ZEUS ELISA Borrelia burgdorferi IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative presumptive detection of IgG antibodies to Borrelia burgdorferi in human serum. This test should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease.
ZEUS SCIENTIFIC, INC.
SM3Z9651G
In Commercial Distribution

  • 00845533000185 ()
SM3Z9651G

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Borrelia burgdorferi IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative presumptive detection of IgG antibodies to Borrelia burgdorferi in human serum. This test should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease.
ZEUS SCIENTIFIC, INC.
3Z9651G
In Commercial Distribution

  • 00845533000178 ()
3Z9651G

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Entamoeba histolytica IgG ELISA is intended for the qualitative determination of IgG class antibodies against Entamoeba histolytica in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3830
In Commercial Distribution

  • 04048474038309 ()
EIA-3830

  • Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
For the qualitative screening of serum or plasma IgG antibodies to Taenia solium using an Enzyme Linked Immunoabsorbant Assay (ELISA) technique
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3513
In Commercial Distribution

  • 04048474035131 ()
EIA-3513

  • Taenia solium immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The E. histolytica ELISA test is a qualitative enzyme immunoassay for the detection of antibodies to E. histolytica, in samples of human serum or plasma.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3474
In Commercial Distribution

  • 04048474034745 ()
EIA-3474

  • Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
This ELISA is an in vitro immunoassay for the qualitative determination of E. histolytica antigen in feces
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3473
Not in Commercial Distribution

  • 04048474034738 ()
EIA-3473

  • Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
VIDAS Lyme IgG II assay is a qualitative immunoassay intended for use on VIDAS family instrument in the presumptive detection of human IgG antibodies to Borrelia burgdorferi.
BIOMERIEUX SA
417401
In Commercial Distribution

  • 03573026458270 ()


  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
AccuDiag™ Taenia.solium (Cysticercosis) IgG ELISA -For the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Taenia solium in a clinical specimen, using an enzyme immunoassay (EIA) method.
Diagnostic Automation, Inc.
DACD8105-35
In Commercial Distribution

  • 00894175000299 ()

  • 96 Tests
8105-35

  • Taenia solium immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Entamoeba histolytica IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3013
In Commercial Distribution

  • B350GSD0130130 ()
GSD01-3013

  • Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Taenia solium ELISA test is a qualitative enzyme immunoassay for the detection of Taenia solium antibodies in human serum samples.
Bordier affinity products S.A.
9700
In Commercial Distribution

  • 07640158219706 ()
9700

  • Taenia solium immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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