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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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No Description
SCIMEDX CORPORATION
I-ECH01X
In Commercial Distribution

  • 00813545025649 ()
I-ECH01X

  • Ehrlichia chaffeensis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
No Description
SCIMEDX CORPORATION
I-EBV03X
In Commercial Distribution

  • 00813545025618 ()
I-EBV03X

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
SCIMEDX CORPORATION
I-EBV03G
In Commercial Distribution

  • 00813545025595 ()
I-EBV03G

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
The Bordetella pertussis Toxin, PT, IgG ELISA is intended for the quantitative determination of IgG class antibodies against B. pertussis toxin, PT, in human serum or plasma, -citrate, heparin.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-6133
Not in Commercial Distribution

  • 04048474061338 ()
EIA-6133

  • Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)
The DRG Bordetella pertussis IgG Enzyme Immunoassay Kit provides materials for the qualitative and semi-quantitative determination of IgG-class antibodies to Bordetella pertussis and Bordetella pertussis toxin in serum and plasma (EDTA-, heparin- or citrate plasma).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3450
In Commercial Distribution

  • 04048474034509 ()
EIA-3450

  • Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Legionella IFA Test System,(Legionella species), 180 Tests
MARDX DIAGNOSTICS, INC.
30-7980
In Commercial Distribution

  • 05391516747820 ()
30-7980

  • Legionella longbeachae immunoglobulin A (IgA)/IgG/IgM 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)
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