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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-CD79a-599 is intended for the qualitative identification by light microscopy of human CD79a protein in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD79A-599-L-CE
Not in Commercial Distribution

  • 05055331325501 ()
NCL-L-CD79a-599

  • CD79a cell marker IVD, antibody
Mammaglobin (EP249) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Mammaglobin 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
PA0378
In Commercial Distribution

  • 05055331325259 ()
PA0378

  • Mammaglobin IVD, antibody
NCL-L-PLK-1 is intended for the qualitative identification by light microscopy of PLK-1 protein in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
PLK-1-L-CE
Not in Commercial Distribution

  • 05055331325235 ()
NCL-L-PLK-1

  • Polo-like kinase-1 (PLK1) IVD, antibody
p120 Catenin (EP66) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human p120 Catenin 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
PA0379
In Commercial Distribution

  • 05055331325228 ()
PA0379

  • Delta-catenin IVD, antibody
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 Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0375
In Commercial Distribution

  • 05055331325211 ()
PA0375

  • Homeobox protein CDX-2 IVD, antibody
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 Leica BONDMAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0374
In Commercial Distribution

  • 05055331325204 ()
PA0374

  • CD103 cell marker IVD, antibody
CD4 (4B12) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD4 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
PA0427
In Commercial Distribution

  • 05055331324801 ()
PA0427

  • CD4 cell marker IVD, antibody
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 Leica BONDMAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0359
In Commercial Distribution

  • 05055331324719 ()
PA0359

  • CD20 cell marker IVD, antibody
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 Leica BONDMAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0200
In Commercial Distribution

  • 05055331324702 ()
PA0200

  • CD20 cell marker IVD, antibody
NCL-L-TOPO I is intended for the qualitative identification by light microscopy of human topoisomerase I in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
TOPOI-L-U
In Commercial Distribution

  • 05055331324115 ()
NCL-L-TOPOI

  • Topoisomerase IIa IVD, antibody
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