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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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Borrelia burgdorferi EIA IgG + IgM
CLARK LABORATORIES, INC.
40-8696P
In Commercial Distribution

  • 05391516746601 ()

  • 96 Tests
40-8696P

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
EB-NA-1 IgG
CLARK LABORATORIES, INC.
72939
In Commercial Distribution

  • 05391516746571 ()

  • 96 Tests
72939

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
EBV-EA-D IgG
CLARK LABORATORIES, INC.
72938
In Commercial Distribution

  • 05391516746564 ()

  • 96 Tests
72938

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
EBV-VCA IgG
CLARK LABORATORIES, INC.
72937
In Commercial Distribution

  • 05391516746557 ()

  • 96 Tests
72937

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
FTA-ABS, 10 Well Slides, 10 each pack
MARDX DIAGNOSTICS, INC.
31-8010
In Commercial Distribution

  • 05391516746397 ()
31-8010

  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
B. burgdorferi EIA (IgG, IgM) Test System (480 Tests)
MARDX DIAGNOSTICS, INC.
40-8696P/J
In Commercial Distribution

  • 05391516746304 ()
40-8696P/J

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
B. burgdorferi EIA (IgG, IgM) Test System (96 Tests)
MARDX DIAGNOSTICS, INC.
40-8696P
In Commercial Distribution

  • 05391516746298 ()
40-8696P

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Legionella IFA Test System, (L. pneumophila, serogroups 1-6), 120 Tests
MARDX DIAGNOSTICS, INC.
30-7120
In Commercial Distribution

  • 05391516746151 ()
30-7120

  • Legionella pneumophila immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ EBNA-1 IgG
CLARK LABORATORIES, INC.
2325800
In Commercial Distribution

  • 05391516743570 ()

  • 96 Tests
2325800

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ EBV EA-D IgG
CLARK LABORATORIES, INC.
2325000
In Commercial Distribution

  • 05391516743365 ()

  • 96 Tests
2325000

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