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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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Fort Worth Diagnostics - 00850051429042

Ehrlichia Primer Set
Fort Worth Diagnostics, LLC
EHR001
In Commercial Distribution

  • 00850051429042 ()
EHR001

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429035

Borrelia Primer Set
Fort Worth Diagnostics, LLC
BOR001
In Commercial Distribution

  • 00850051429035 ()
BOR001

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429028

Anaplasma Primer Set
Fort Worth Diagnostics, LLC
ANA001
In Commercial Distribution

  • 00850051429028 ()
ANA001

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429004

Babesia Primer Set
Fort Worth Diagnostics, LLC
BAB001
In Commercial Distribution

  • 00850051429004 ()
BAB001

  • Assay development analyte-specific reagent IVD

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
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