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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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QMedix™ Lyme IgG/IgM ELISA This test is intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Borrelia burgdorferi in a clinical specimen, using an enzyme immunoassay (EIA) method.
Diagnostic Automation, Inc.
DACD1423-55
In Commercial Distribution

  • 00850054026378 ()

  • 96 Tests
1423-55

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Alkaline Phosphatase Developing Solution, 110mL
MARDX DIAGNOSTICS, INC.
44-5017
In Commercial Distribution

  • 05391516747707 ()
44-5017

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
10x Sample Diluent/Wash Solution, 100 mL
MARDX DIAGNOSTICS, INC.
40-2019C
In Commercial Distribution

  • 05391516747653 ()
40-2019C

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Captia Borrelia burgdorferi IgG/IgM
CLARK LABORATORIES, INC.
2346581
In Commercial Distribution

  • 05391516747486 ()

  • 480 Tests
2346581

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ Borrelia burgdorferi IgG/IgM
CLARK LABORATORIES, INC.
2346580
In Commercial Distribution

  • 05391516747189 ()

  • 96 tests
2346580

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ EBNA-1 IgG
CLARK LABORATORIES, INC.
2325801
In Commercial Distribution

  • 05391516747097 ()

  • 480 Tests
2325801

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ EBV VCA IgG
CLARK LABORATORIES, INC.
2325700
In Commercial Distribution

  • 05391516747073 ()

  • 96 Tests
2325700

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ EBV EA-D IgG
CLARK LABORATORIES, INC.
2325001
In Commercial Distribution

  • 05391516746953 ()

  • 480 Tests
2325001

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ EBV VCA P-18 IgG
CLARK LABORATORIES, INC.
2324701
In Commercial Distribution

  • 05391516746946 ()

  • 480 Tests
2324701

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Borrelia burgdorferi EIA IgG + IgM
CLARK LABORATORIES, INC.
40-8696P/J
In Commercial Distribution

  • 05391516746618 ()

  • 480 Tests
40-8696P/J

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