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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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BOND - 05055331334961

CDX2 (EP25) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CDX2 protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0375-U
In Commercial Distribution

  • 05055331334961 ()
PA0375-U

  • Homeobox protein CDX-2 IVD, antibody

BOND™ - 05055331334954

CD103 (EP206) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD103 protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0374-U
In Commercial Distribution

  • 05055331334954 ()
PA0374-U

  • CD103 cell marker IVD, antibody

BOND™ - 05055331334947

Mesothelin (5B2) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human mesothelin protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0373-U
In Commercial Distribution

  • 05055331334947 ()
PA0373-U

  • Mesothelin IVD, antibody

BOND - 05055331334930

Neurofilament 200 kD (N52.1.7) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of the NF-H (200 kD) subunit of human neurofilament in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0371-U
In Commercial Distribution

  • 05055331334930 ()
PA0371-U

  • Neurofilament protein IVD, antibody

BOND - 05055331334923

Thyroid Transcription Factor-1 (SPT24) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human thyroid transcription factor-1 in formalin-fixed paraffin-embedded tissue by immunohistochemical staining using the automated BOND system includes BOND-MAX BOND-III and BOND-PRIME systems.
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0364-U
In Commercial Distribution

  • 05055331334923 ()
PA0364-U

  • Thyroid transcription factor-1 (TTF1) IVD, antibody

BOND™ - 05055331334916

TIM-3 (EPR22241) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human TIM-3 protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0360-U
In Commercial Distribution

  • 05055331334916 ()
PA0360-U

  • T-cell immunoglobulin and mucin domain-containing protein 3 (TIM-3) IVD, antibody

BOND - 05055331334909

CD20 (L26) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD20 protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0359-U
In Commercial Distribution

  • 05055331334909 ()
PA0359-U

  • CD20 cell marker IVD, antibody

BOND - 05055331334893

CD34 (QBEnd/10) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human endothelial cell marker (CD34) in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0354-U
In Commercial Distribution

  • 05055331334893 ()
PA0354-U

  • CD34 cell marker IVD, antibody

BOND - 05055331334886

Calretinin (CAL6) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human calretinin in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0346-U
In Commercial Distribution

  • 05055331334886 ()
PA0346-U

  • Calretinin protein IVD, antibody

BOND™ - 05055331334879

Terminal Deoxynucleotidyl Transferase (SEN28) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human terminal deoxynucleotidyl transferase (TdT) in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0339-U
In Commercial Distribution

  • 05055331334879 ()
PA0339-U

  • Terminal deoxynucleotidyl transferase (TdT) IVD, antibody
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