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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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NCL-L-VIM-V9 is intended for the qualitative identification by light microscopy of human vimentin intermediate filament protein in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
VIM-V9-L-CE-H
Not in Commercial Distribution

  • 05055331321770 ()
NCL-L-VIM-V9

  • Vimentin IVD, antibody
NCL-L-CK20 is intended for the qualitative identification by light microscopy of human cytokeratin 20 intermediate filament protein in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CK20-L-CE-H
In Commercial Distribution

  • 05055331321725 ()
NCL-L-CK20

  • Cytokeratin IVD, antibody
Vimentin (V9) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human vimentin in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0640
In Commercial Distribution

  • 05055331321596 ()
PA0640

  • Vimentin IVD, antibody
Ki67 (MM1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Ki67 nuclear antigen in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0410
In Commercial Distribution

  • 05055331321589 ()
PA0410

  • Ki67 antigen IVD, antibody
Gross Cystic Disease Fluid Protein-15 (23A3) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human gross cystic disease fluid protein (15 kD) in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0708
In Commercial Distribution

  • 05055331321572 ()
PA0708

  • Gross cystic disease fluid protein-15 IVD, antibody
p63 (7JUL) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human p63 protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0103
In Commercial Distribution

  • 05055331321565 ()
PA0103

  • p63 tumour protein IVD, antibody
Cytokeratin 20 (Ks20.8) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratin 20 intermediate filament protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0037
In Commercial Distribution

  • 05055331321558 ()
PA0037

  • Cytokeratin IVD, antibody
Cytokeratin 20 (Ks20.8) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratin 20 intermediate filament protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0022
In Commercial Distribution

  • 05055331321541 ()
PA0022

  • Cytokeratin IVD, antibody
NCL-L-LANGERIN-U is intended for the qualitative identification by light microscopy of human langerin in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
LANGERIN-L-U
In Commercial Distribution

  • 05055331321435 ()
NCL-L-LANGERIN-U

  • CD207 cell marker IVD, antibody
NCL-L-CD71-309-U is intended for the qualitative identification by light microscopy of human CD71 molecules in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD71-309-L-U
In Commercial Distribution

  • 05055331321428 ()
NCL-L-CD71-309-U

  • CD71 cell marker IVD, antibody
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