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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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Ki67 (MM1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Ki67 antigen in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0118-U
In Commercial Distribution

  • 05055331334428 ()
PA0118-U

  • Ki67 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 BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0117-U
In Commercial Distribution

  • 05055331334411 ()
PA0117-U

  • Bcl-2 oncoprotein IVD, antibody
Muc-6 Glycoprotein (CLH5) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Muc-6 glycoprotein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0053-U
In Commercial Distribution

  • 05055331334275 ()
PA0053-U

  • Mucin IVD, antibody
Muc-5AC Glycoprotein (CLH2) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Muc-5AC glycoprotein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0052-U
In Commercial Distribution

  • 05055331334268 ()
PA0052-U

  • Mucin IVD, antibody
Muc-1 Glycoprotein (Ma695) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Muc-1 glycoprotein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0051-U
In Commercial Distribution

  • 05055331334251 ()
PA00051-U

  • Mucin IVD, antibody
Cyclin D1 (EP12) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of cyclin D1 protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX system, BOND-III system and BOND-PRIME system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0046-U
In Commercial Distribution

  • 05055331334237 ()
PA0046-U

  • Cyclin D1 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 BOND-MAX system, BOND-III system and BOND-PRIME system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0032-U
In Commercial Distribution

  • 05055331334183 ()
PA0032-U

  • Desmin protein 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 BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0016-U
In Commercial Distribution

  • 05055331334121 ()
PA0016-U

  • p16 antigen IVD, antibody
NCL-L-NapsinA-U is intended for the qualitative identification by light microscopy of Napsin A molecules in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
NAPSINA-L-U
In Commercial Distribution

  • 05055331334039 ()
NCL-L-NAPSINA-U

  • Napsin A IVD, antibody
NCL-L-MSH6-U is intended for the qualitative identification by light microscopy of Mismatch Repair Protein 6 (MSH6) molecules in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
MSH6-L-U
In Commercial Distribution

  • 05055331334008 ()
NCL-L-MSH6-U

  • MSH6 antigen IVD, antibody
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