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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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ARCHITECT - 00380740175474

ARCHITECT STAT High Sensitivity Troponin-I Calibrators
ABBOTT IRELAND
02R9801
In Commercial Distribution

  • 00380740175474 ()
02R9801

  • Troponin I IVD, calibrator

Alinity - 00380740155360

Alinity I Intact PTH Calibrators
Abbott GmbH
08P3102
In Commercial Distribution

  • 00380740155360 ()
08P3102

  • Parathyroid hormone (PTH) IVD, calibrator

Kallestad - 00847865001724

Kallestad Mouse Stomach/Kidney 8 Well Slides
Bio-RAD Laboratories, Inc.
26115
In Commercial Distribution

  • 00847865001724 ()

  • 8 Well
  • 160 Tests
26115

  • Multiple antinuclear antibody (ANA) screening IVD, reagent

Kallestad - 00847865001717

Kallestad Mouse Stomach/Kidney 8 Well Slides
Bio-RAD Laboratories, Inc.
26112
In Commercial Distribution

  • 00847865001717 ()

  • 8 Well
  • 800 Tests
26112

  • Multiple antinuclear antibody (ANA) screening IVD, reagent

Kallestad - 00847865001700

Kallestad Mouse Stomach/Kidney 8 Well Slides
Bio-RAD Laboratories, Inc.
26111
In Commercial Distribution

  • 00847865001700 ()

  • 48 Tests
  • 8 Well
26111

  • Multiple antinuclear antibody (ANA) screening IVD, reagent

Kallestad - 00847865001571

Kallestad Crithidia luciliae 8 Well Slides
Bio-RAD Laboratories, Inc.
26110
In Commercial Distribution

  • 00847865001571 ()

  • 160 Tests
  • 8 Wells
26110

  • Native DNA antibody (anti-nDNA) IVD, reagent

Kallestad - 00847865001564

Kallestad Crithidia luciliae 8 Well Slides
Bio-RAD Laboratories, Inc.
26109
In Commercial Distribution

  • 00847865001564 ()

  • 48 Tests
  • 8 Wells
26109

  • Native DNA antibody (anti-nDNA) IVD, reagent

Kallestad - 00847865001557

Kallestad Crithidia luciliae 4 Well Slides
Bio-RAD Laboratories, Inc.
26108
In Commercial Distribution

  • 00847865001557 ()

  • 4 Wells
  • 80 Tests
26108

  • Native DNA antibody (anti-nDNA) IVD, reagent

Kallestad - 00847865001540

Kallestad Crithidia luciliae 4 Well Slides
Bio-RAD Laboratories, Inc.
26107
In Commercial Distribution

  • 00847865001540 ()

  • 4 Wells
  • 24 Tests
26107

  • Native DNA antibody (anti-nDNA) IVD, reagent

Liquichek - 00847661004516

Liquichek D-dimer Control MiniPak (A processed human plasma assayed D-dimer control.)
BIO-RAD LABORATORIES, INC.
27102X
In Commercial Distribution

  • 00847661004516 ()
27102X

  • D-dimer IVD, control
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