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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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Captia™ Legionella pneumophila IgG/IgM
CLARK LABORATORIES, INC.
2346980
In Commercial Distribution

  • 05391516747202 ()

  • 96 Tests
2346980

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Custom - EBNA FA BP - 3900 wells
IMMUNO CONCEPTS INC
8131
In Commercial Distribution

  • M7490081311 ()
8131

  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
The DRG Epstein Barr Virus Early Antigen (EBV-EA) IgG ELISA test system provides a means for the qualitative detection of IgG class antibodies to Epstein-Barr Virus (EBV) Early Antigen (EA) in human sera. This test is intended to aid in the diagnosis of infectious mononucleosis (IM) when used with other EBV serological tests. The performance characteristics have not been established to aid in the diagnosis of acute IM.
DRG International Inc
EIA-2796
Not in Commercial Distribution

  • 00840239027962 ()
EIA-2796

  • Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)
The DRG Epstein Barr Virus – Viral Capsid antigen (EBV-VCA) IgG test system is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG class antibodies to Epstein-Barr Virus Viral Capsid Antigen in human serum. The Test System is intended to be used to evaluate serologic evidence of previous infection with Epstein-Barr Virus
DRG International Inc
EIA-2793
Not in Commercial Distribution

  • 00840239027931 ()
EIA-2793

  • Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)
The ZEUS IFA Epstein-Barr Virus Nuclear Antigen (EBV-NA) anti-complement immunofluorescence (ACIF) Test System is a relatively rapid and sensitive method for the qualitative and semi-quantitative detection of antibodies to the nuclear antigen of Epstein-Barr virus in human sera. When performed according to instructions, this assay can provide information on infectious mononucleosis (IM) that may be of value in patient management and treatment. This device is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
FA9153
In Commercial Distribution

  • 00845533001625 ()
FA9153

  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
The ZEUS ELISA Legionella pneumophila IgG/IgM/IgA Test System is an enzyme-linked immunosorbent assay for the qualitative detection of total antibody (IgG/IgM/IgA) to Legionella pneumophila serogroups 1-6 in human sera. This device is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
SM3Z15051
In Commercial Distribution

  • 00845533000796 ()
SM3Z15051

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Legionella pneumophila IgG/IgM/IgA Test System is an enzyme-linked immunosorbent assay for the qualitative detection of total antibody (IgG/IgM/IgA) to Legionella pneumophila serogroups 1-6 in human sera. This device is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
3Z15051
In Commercial Distribution

  • 00845533000789 ()
3Z15051

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgG Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG class antibodies to Epstein-Barr Virus Viral Capsid Antigen in human serum. The Test System is intended to be used to evaluate serologic evidence of previous infection with Epstein-Barr Virus, and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
SM9Z9201G
In Commercial Distribution

  • 00845533000482 ()
SM9Z9201G

  • Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgG Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG class antibodies to Epstein-Barr Virus Viral Capsid Antigen in human serum. The Test System is intended to be used to evaluate serologic evidence of previous infection with Epstein-Barr Virus, and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q9Z9201GB
In Commercial Distribution

  • 00845533000475 ()
Q9Z9201GB

  • Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgG Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG class antibodies to Epstein-Barr Virus Viral Capsid Antigen in human serum. The Test System is intended to be used to evaluate serologic evidence of previous infection with Epstein-Barr Virus, and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
9Z9201G
In Commercial Distribution

  • 00845533000468 ()
9Z9201G

  • Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)
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