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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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CHORUS ECHINOCOCCUS IgG - 08033891320010

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)

Bio-Rad - 03610522051243

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 - 03610520506462

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

BioPlex 2200 - 03610520506455

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 - 03610520506394

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

LIAISON Lyme Total Antibody Plus - 08056771602709

No Description
Diasorin Inc.
318330
In Commercial Distribution

  • 08056771602709 ()


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

LIAISON® Borrelia burgdorferi - 08056771600262

No Description
Diasorin Inc.
310870
In Commercial Distribution

  • 08056771600262 ()
  • 18056771600269 ()


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

LIAISON® VCA IgG - 08056771101714

No Description
DIASORIN SPA
310510
In Commercial Distribution

  • 08056771101714 ()


  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

VIDAS® Lyme IgG and IgM - 03573026156879

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)

Echinococcus IgG ELISA Test Kit - B350GSD0130030

Echinococcus IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3003
In Commercial Distribution

  • B350GSD0130030 ()
GSD01-3003

  • Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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