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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 - 05391516747622

B. burgdorferi WB IgG Serum Band Locator, 250µL
MARDX DIAGNOSTICS, INC.
40-2023L
In Commercial Distribution

  • 05391516747622 ()
40-2023L

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

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)

Trinity Biotech - 05391516746281

B. burgdorferi EIA (IgM) Test System (480 Tests)
MARDX DIAGNOSTICS, INC.
40-8696M/J
In Commercial Distribution

  • 05391516746281 ()
40-8696M/J

  • Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516746274

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

  • 05391516746274 ()
40-8696M

  • Borrelia burgdorferi immunoglobulin M (IgM) 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 - 05391516744775

Hemoglobin A1c assay, Premier Buffer B Reagent - 940mL
PRIMUS CORPORATION
Premier Buffer B Reagent - 940mL
In Commercial Distribution

  • 05391516744775 ()

  • Total Volume: 940 Milliliter
01-03-0096

  • Glycated haemoglobin (HbA1c) IVD, reagent

Trinity Biotech - 05391516744171

Hemoglobin A1c assay, Ultra2 Buffer B Reagent - 3.8L
PRIMUS CORPORATION
Ultra2 Buffer B Reagent - 3.8L
In Commercial Distribution

  • 05391516744171 ()

  • Total Volume: 3.8 Liter
01-03-0012

  • Glycated haemoglobin (HbA1c) IVD, reagent

Trinity Biotech - 05391516744164

Hemoglobin A1c assay, Ultra2 Buffer B Reagent - 940mL
PRIMUS CORPORATION
Ultra2 Buffer B Reagent - 940mL
In Commercial Distribution

  • 05391516744164 ()

  • Total Volume: 940 Milliliter
01-03-0011

  • Glycated haemoglobin (HbA1c) IVD, reagent

NA - 00643169783348

CUSTOM PACK TL9H74R1 4PK XP8 1 W/B
MEDTRONIC, INC.
TL9H74R1
Not in Commercial Distribution

  • 20643169783359 ()
  • 00643169783348 ()


  • Cardiopulmonary bypass system blood tubing set

NA - 00643169855175

CUSTOM PACK CB9L24R 5PK L I M B
MEDTRONIC, INC.
CB9L24R
In Commercial Distribution

  • 20643169855186 ()
  • 00643169855175 ()


  • Cardiopulmonary bypass system blood tubing set
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