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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 - 05391516747608

B. burgdorferi 10 Well Slides, 10 each pack
MARDX DIAGNOSTICS, INC.
32-5010
In Commercial Distribution

  • 05391516747608 ()
32-5010

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

MarDx - 05391516746625

Borrelia burgdorferi EIA IgG
CLARK LABORATORIES, INC.
40-8696G
In Commercial Distribution

  • 05391516746625 ()

  • 96 Tests
40-8696G

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

Trinity Biotech - 05391516746267

B. burgdorferi EIA (IgG) Test System (96 Tests)
MARDX DIAGNOSTICS, INC.
40-8696G
In Commercial Distribution

  • 05391516746267 ()
40-8696G

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

Trinity Biotech - 05391516746236

B. burgdorferi (IgG) Marblot Strip Test System (400 Tests)
MARDX DIAGNOSTICS, INC.
40-5065G/B
In Commercial Distribution

  • 05391516746236 ()
40-5065G/B

  • Borrelia garinii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516746229

B. burgdorferi (IgG) Marblot Strip Test System (50 Tests)
MARDX DIAGNOSTICS, INC.
40-5065G
In Commercial Distribution

  • 05391516746229 ()
40-5065G

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

Trinity Biotech - 05391516746205

B. burgdorferi (IgG) Marblot Strip Test System (20 Tests)
MARDX DIAGNOSTICS, INC.
40-2075G
In Commercial Distribution

  • 05391516746205 ()
40-2075G

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

Trinity Biotech - 05391516744836

CAPTIA™ Syphilis (T. Pallidum)-G
CLARK LABORATORIES, INC.
800-960
In Commercial Distribution

  • 05391516744836 ()

  • 960 Tests
800-960

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516744829

CAPTIA™Syphilis (T. Pallidum)-G
CLARK LABORATORIES, INC.
800-970
In Commercial Distribution

  • 05391516744829 ()

  • 96 Tests
800-970

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

SeraQuest - 00850487007609

Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
Syphilis G
In Commercial Distribution

  • 00850487007609 ()
Q01-580

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ReQuest - 00850487007043

Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
Syphilis G
In Commercial Distribution

  • 00850487007043 ()
Q01-580

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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