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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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Trinity Biotech - 05391516747653

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)

Trinity Biotech - 05391516747486

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)

Trinity Biotech - 05391516747189

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)

MarDx - 05391516746618

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)

MarDx - 05391516746601

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)

Trinity Biotech - 05391516746397

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)

Trinity Biotech - 05391516746304

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)

Trinity Biotech - 05391516746298

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)

Trinity Biotech - 05391516746151

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)

QMedix™ - 00850054026378

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)
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