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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 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)
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)
BioPlex 2200 Lyme Total Assay Protocol File CD SW4.3_v1.0
BIO-RAD LABORATORIES, INC.
4.3_v1.0
In Commercial Distribution

  • 03610520506462 ()

  • 1 Each
12000883

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay
U.S. IFU, Canada IFU (United States, Canada) Manual & CDs, BioPlex 2200 Lyme Total IFU SW4.3_v1.0
BIO-RAD LABORATORIES, INC.
4.3_v1.0
In Commercial Distribution

  • 03610520506455 ()

  • 1 Each
12000882

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay
BioPlex 2200 Lyme Total 200 Tests
BIO-RAD LABORATORIES, INC.
12000876
In Commercial Distribution

  • 03610520506394 ()

  • 200 Tests
12000876

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay
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
No Description
DIESSE DIAGNOSTICA SENESE SPA
81284
In Commercial Distribution

  • 08033891320010 ()
81284

  • Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
AccuDiag ™ Borrelia burgdorferi IgG/IgM 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.
Diagnostic Automation, Inc.
DACD-1423-2
In Commercial Distribution

  • 00894175000022 ()

  • 96 tests
1423-2

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