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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.
SM3Z9651
In Commercial Distribution

  • 00845533000239 ()
SM3Z9651

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
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.
3Z9651B
In Commercial Distribution

  • 00845533000222 ()
3Z9651B

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
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)
The ZEUS AtheNA Multi-Lyte® Epstein-Barr Virus - Viral Capsid Antigen (EBV-VCA) IgM Plus Test System is a microparticle-based immunoassay intended for the qualitative detection of IgM class antibody to the Epstein-Barr virus, viral capsid antigen in human serum using the AtheNA Multi-Lyte System. The test system is intended to be used for the laboratory diagnosis of EBV-associated infectious mononucleosis and provides epidemiological information on the diseases caused by Epstein-Barr virus. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants. Assay performance characteristics have not been established for the diagnosis of nasopharyngeal carcinoma, Burkitt's lymphoma, and other EBV-associated lymphomas. This test is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
A92101M
In Commercial Distribution

  • 00845533000048 ()
A92101M

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgM class antibodies to Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) in human sera. The Test System is intended to be used for the diagnosis of EBV-associated infectious mononucleosis when used in conjunction with other EBV serological assays. This test is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
SM9Z9201M
In Commercial Distribution

  • 00845533000512 ()
SM9Z9201M

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgM class antibodies to Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) in human sera. The Test System is intended to be used for the diagnosis of EBV-associated infectious mononucleosis when used in conjunction with other EBV serological assays. This test is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
Q9Z9201MB
In Commercial Distribution

  • 00845533000505 ()
Q9Z9201MB

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgM class antibodies to Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) in human sera. The Test System is intended to be used for the diagnosis of EBV-associated infectious mononucleosis when used in conjunction with other EBV serological assays. This test is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
9Z9201M
In Commercial Distribution

  • 00845533000499 ()
9Z9201M

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Anti-Borrelia (Lyme) EIA, Conjugate
Bio-RAD Laboratories, Inc.
25274
In Commercial Distribution

  • 00847865011495 ()

  • Total Volume: 12 Milliliter
25274

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Anti-Borrelia (Lyme) EIA, Borrelia Blocker
Bio-RAD Laboratories, Inc.
25272
In Commercial Distribution

  • 00847865011488 ()

  • Total Volume: 25 Milliliter
25272

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Anti-Borrelia (Lyme) EIA, Positive Control
Bio-RAD Laboratories, Inc.
25271
In Commercial Distribution

  • 00847865011471 ()

  • Total Volume: 0.1 Milliliter
25271

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
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