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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/IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative presumptive detection of total (IgG and IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA 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.
3Z9651
In Commercial Distribution

  • 00845533000215 ()
3Z9651

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
BD Horizon Mouse IgG1 (X40) BV786 ASR
Becton, Dickinson And Company
664537
In Commercial Distribution

  • 00382906645371 ()
664537

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
BD Horizon Mouse IgG1 (X40) BV711 ASR
Becton, Dickinson And Company
664526
In Commercial Distribution

  • 00382906645265 ()
664526

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
BD Horizon™ Mouse IgG1 (X40) BV421
Becton, Dickinson And Company
659453
In Commercial Distribution

  • 00382906594532 ()
659453

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
BD Horizon Mouse IgG1 (X40) V500-C ASR
Becton, Dickinson And Company
647452
In Commercial Distribution

  • 00382906474520 ()
647452

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
BD Horizon™ Mouse IgG1 (X40) V450
Becton, Dickinson And Company
642277
In Commercial Distribution

  • 00382906422774 ()
642277

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
BD® Mouse IgG1 (X40) APC-Cy7
Becton, Dickinson And Company
348802
In Commercial Distribution

  • 00382903488025 ()
348802

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
Ms IgG1 Isotype Control PE-Cy7 X40 ASR
Becton, Dickinson And Company
348798
In Commercial Distribution

  • 00382903487981 ()
348798

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
BD® Mouse IgG1 (X40) PerCP-Cy5.5
Becton, Dickinson And Company
347212
In Commercial Distribution

  • 00382903472123 ()
347212

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
Ms IgG2a Isotype Control PerCP X39 ASR
Becton, Dickinson And Company
340765
In Commercial Distribution

  • 00382903407651 ()
340765

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
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