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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
EUROIMMUN Medizinische Labordiagnostika AG
AF 102-0540-R
In Commercial Distribution

  • 04049016151234 ()


  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
The VIDAS ® Lyme IgG and IgM assay for use on VIDAS family instruments for the presumptive detection of total antibodies (IgG/IgM) to Borrelia burgdorferi
BIOMERIEUX SA
30298-01
Not in Commercial Distribution

  • 03573026156879 ()


  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Diasorin Inc.
318330
In Commercial Distribution

  • 08056771602709 ()


  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay
No Description
Diasorin Inc.
310870
In Commercial Distribution

  • 08056771600262 ()
  • 18056771600269 ()


  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay
No Description
DIASORIN SPA
310510
In Commercial Distribution

  • 08056771101714 ()


  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
EBV EA-D IgG EIA TEST
Bio-RAD Laboratories, Inc.
12008530
In Commercial Distribution

  • 03610522051243 ()

  • 96 Tests
12008530

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The COVID-19 total Ab is designed for the qualitative and quantitative measurement of anti-coronavirus IgG and IgM in human serum and plasma (Li-heparinized, EDTA, and citrate) by fluorescence immunoassay (FIA) using the FREND™ System.
NanoEnTek, Inc.
FREND COVID-19 total Ab
In Commercial Distribution

  • 08809317540924 ()
FRCOA 020

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
The Borrelia burgdorferi IgG/IgM ELISA test system is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG and IgM class antibodies to Borrelia burgdorferi in human serum. This assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme disease
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2809
In Commercial Distribution

  • 04048474028096 ()
EIA-2809

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
The Borrelia burgdorferi IgM ELISA test system is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgM class antibody to Borrelia burgdorferi in human serum. This assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme disease.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2811
In Commercial Distribution

  • 04048474028119 ()
EIA-2811

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
The Borrelia burgdorferi IgG ELISA test system is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG class antibody to Borrelia burgdorferi in human serum. This assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme disease
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2810
In Commercial Distribution

  • 04048474028102 ()
EIA-2810

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