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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-InhibinA is intended for the qualitative identification by light microscopy of inhibin alpha molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
INHIBINA-L-CE
In Commercial Distribution

  • 05055331318350 ()
NCL-L-InhibinA

  • Inhibin A IVD, antibody
MLH1 (Mismatch Repair Protein) (ES05) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human mismatch repair protein (MLH1) 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
PA0610
In Commercial Distribution

  • 05055331318060 ()
PA0610

  • MLH1 antigen IVD, antibody
Ki67 (K2) 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 an automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0230
In Commercial Distribution

  • 05055331318053 ()
PA0230

  • Ki67 antigen IVD, antibody
Galectin-3 (9C4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human galectin-3 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0238
In Commercial Distribution

  • 05055331317902 ()
PA0238

  • Galectin-3 IVD, antibody
NCL-L-bcl-2 is intended for the qualitative identification by light microscopy of human bcl-2 oncoprotein in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
BCL-2-L-CE
In Commercial Distribution

  • 05055331316226 ()
NCL-L-bcl-2

  • Bcl-2 oncoprotein IVD, antibody
NCL-L-Bcl-6-564 is intended for the qualitative identification by light microscopy of human Bcl-6 oncoprotein in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
BCL-6-564-L-CE
In Commercial Distribution

  • 05055331316141 ()
NCL-L-Bcl-6-564

  • Bcl-6 protein IVD, antibody
NCL-L-CAIX is intended for the qualitative identification by light microscopy of Carbonic Anhydrase IX molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CAIX-L-CE
In Commercial Distribution

  • 05055331315762 ()
NCL-L-CAIX

  • Carbonic anhydrase IVD, antibody
NCL-L-CALRET-566 is intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CALRET566-L-CE
In Commercial Distribution

  • 05055331315571 ()
NCL-L-CALRET-566

  • Calretinin protein IVD, antibody
NCL-L-CYCLIN D1-GM is intended for the qualitative identification by light microscopy of Cyclin D1 molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CYCLIND1-GM-L-CE
In Commercial Distribution

  • 05055331310897 ()
NCL-L-CYCLIND1-GM

  • Cyclin D1 IVD, antibody
NCL-L-DES-DERII is intended for the qualitative identification by light microscopy of human desmin in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
DES-DERII-L-CE
In Commercial Distribution

  • 05055331310668 ()
NCL-L-DES-DERII

  • Desmin protein IVD, antibody
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