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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-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
NCL-L-AFP-U is intended for the qualitative identification by light microscopy of human alpha fetoprotein in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
AFP-L-U
In Commercial Distribution

  • 05055331324108 ()
NCL-L-AFP-U

  • Alpha-fetoprotein (AFP) IVD, antibody
For in vitro diagnostic use. NCL-L-CD146 is intended for the qualitative identification by light microscopy of human CD146 in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist. NCL-L-CD146 is recommended for the assessment of CD146 (MCAM) protein expression in normal and neoplastic tissues.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD146-L-U
In Commercial Distribution

  • 05055331324078 ()
NCL-L-CD146

  • Multiple CD cell marker IVD, antibody
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