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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 - 05391516748742

EU – Lyme IgM Western Blot, Western Blot Test System for the Detection of IgM Antibodies to Borrelia afzelii “PKO” and Borrelia garinii, 40 Tests
MARDX DIAGNOSTICS, INC.
44-2020M
In Commercial Distribution

  • 05391516748742 ()
44-2020M

  • Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

Trinity Biotech - 05391516748735

EU Lyme + VlsE IgG Western Blot, Western Blot Test System for the Detection of IgG Antibodies to Borrelia afzelii “PKO”, Borrelia garinii, and Borrelia burgdorferi VlsE, 40 Tests
MARDX DIAGNOSTICS, INC.
44-2020GV
In Commercial Distribution

  • 05391516748735 ()
44-2020GV

  • Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

Trinity Biotech - 05391516746199

Lyme Disease IgM IFA Test System (100 Tests)
MARDX DIAGNOSTICS, INC.
32-5100M
In Commercial Distribution

  • 05391516746199 ()
32-5100M

  • Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

Trinity Biotech - 05391516746182

Lyme Disease IgG IFA Test System (100 Tests)
MARDX DIAGNOSTICS, INC.
32-5100G
In Commercial Distribution

  • 05391516746182 ()
32-5100G

  • Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

Unimed - 06945664803991

Reusable SpO2 Sensor/龙美尔/Finger Clip/Adult/3.0M/111
Unimed Medical Supplies, Inc.
U410-64
In Commercial Distribution

  • 06945664803991 ()


  • Pulse oximeter probe, reusable

Unimed - 06945664822039

Reusable SpO2 Sensor/上海喜鹊/Finger clip/Adult/3.0M/025
Unimed Medical Supplies, Inc.
U410-173D
In Commercial Distribution

  • 06945664822039 ()


  • Pulse oximeter probe, reusable

TECOtherm - 04260647540314

No Description
Tec Com Medizintechnik GmbH
NEO
In Commercial Distribution

  • 04260647540314 ()
8289830

  • External circulating-fluid core temperature regulation system control unit, heating/cooling

Anti Human Complement C-3 Proactivator FITC - B1761062

Fluorescein conjugated polyclonal goat antiserum to Human complement C-3 Proactivator (Factor B)
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761062 ()
106202

  • Complement factor B IVD, kit precipitation/immunodiffusion

Anti Human C-3 Proactivator (Factor B) - B1761060

goat antiserum to Human C-3 Proactivator
KENT LABORATORIES INC
1
Not in Commercial Distribution

  • B1761060 ()
106002

  • Complement factor B IVD, kit precipitation/immunodiffusion

Medline Industries, Inc. - 10193489986297

3 PORT KIT COM HOSP
MEDLINE INDUSTRIES, INC.
650311521
In Commercial Distribution

  • 40193489986298 ()
  • 10193489986297 ()
650311521

  • General surgical procedure kit, non-medicated, single-use
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