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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-CAIX-U is intended for the qualitative identification by light microscopy of Carbonic Anhydrase IX molecules in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CAIX-L-U
In Commercial Distribution

  • 05055331333254 ()
NCL-L-CAIX-U

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

  • 05055331333216 ()
NCL-L-BCL-6-564-U

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

  • 05055331333209 ()
NCL-L-BCL-2-U

  • Bcl-2 oncoprotein IVD, antibody
NCL-L-AR-318-U is intended for the qualitative identification by light microscopy of androgen receptor protein in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
AR-318-L-U
In Commercial Distribution

  • 05055331333179 ()
NCL-L-AR-318-U

  • Androgen receptor IVD, antibody
Muc-4 Glycoprotein (EPR9308) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of Muc-4 Glycoprotein 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
PA0444
In Commercial Distribution

  • 05055331331151 ()
PA0444

  • Mucin IVD, antibody
p16 (6H12) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human p16 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
PA0016
In Commercial Distribution

  • 05055331329684 ()
PA0016

  • p16 antigen IVD, antibody
MLH1 (Mismatch Repair Protein) (ES05) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of 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
PA0988
Not in Commercial Distribution

  • 05055331328847 ()
PA0988

  • MLH1 antigen IVD, antibody
MSH2 (Mismatch Repair Protein) (79H11) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of 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
PA0989
Not in Commercial Distribution

  • 05055331328830 ()
PA0989

  • MSH2 antigen IVD, antibody
MSH6 (Mismatch Repair Protein) (EP49) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of MSH6 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
PA0990
Not in Commercial Distribution

  • 05055331328816 ()
PA0990

  • MSH6 antigen IVD, antibody
NCL-L-MSH2-612 is intended for the qualitative identification by light microscopy of Mismatch Repair Protein 2 (MSH2) in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
MSH2-612-L-CE
In Commercial Distribution

  • 05055331328809 ()
NCL-L-MSH2-612

  • MSH2 antigen IVD, antibody
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