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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-MSH6 is intended for the qualitative identification by light microscopy of Mismatch Repair Protein 6 (MSH6) molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
MSH6-L-CE
In Commercial Distribution

  • 05055331306074 ()
NCL-L-MSH6

  • MSH6 antigen IVD, antibody
NCL-L-Napsin A is intended for the qualitative identification by light microscopy of Napsin A molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
NAPSINA-L-CE
In Commercial Distribution

  • 05055331305572 ()
NCL-L-Napsin A

  • Napsin A IVD, antibody
Desmin (DE-R-11) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human desmin 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
PA0032
In Commercial Distribution

  • 05055331304728 ()
PA0032

  • Desmin protein IVD, antibody
MSH2 (Mismatch Repair Protein) (25D12) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human MSH2 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
PA0048
Not in Commercial Distribution

  • 05055331304674 ()
PA0048

  • MSH2 antigen IVD, antibody
Bcl-2 (bcl-2/100/D5) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Bcl-2 oncoprotein 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
PA0117
In Commercial Distribution

  • 05055331304612 ()
PA0117

  • Bcl-2 oncoprotein 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
PA0118
In Commercial Distribution

  • 05055331304605 ()
PA0118

  • Ki67 antigen IVD, antibody
Alpha Fetoprotein (C3) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human alpha fetoprotein 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
PA0963
In Commercial Distribution

  • 05055331303714 ()
PA0963

  • Alpha-fetoprotein (AFP) 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
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