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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-Geminin is intended for the qualitative identification by light microscopy of Geminin molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
GEMININ-L-CE
In Commercial Distribution

  • 05055331308825 ()
NCL-L-Geminin

  • Geminin IVD, antibody
NCL-Hamlet-2 is intended for the qualitative identification by light microscopy of Dysferlin by immunohistochemistry.
LEICA BIOSYSTEMS NEWCASTLE LTD
HAMLET-2-CE
Not in Commercial Distribution

  • 05055331308528 ()
NCL-Hamlet-2

  • Dysferlin IVD, antibody
NCL-Hamlet is intended for the qualitative identification by light microscopy of Dysferlin by immunohistochemistry.
LEICA BIOSYSTEMS NEWCASTLE LTD
HAMLET-CE
Not in Commercial Distribution

  • 05055331308511 ()
NCL-HAMLET

  • Dysferlin IVD, antibody
NCL-MEROSIN is intended for the qualitative identification by light microscopy of Merosin Laminin Alpha 2 Chain by immunohistochemistry.
LEICA BIOSYSTEMS NEWCASTLE LTD
MEROSIN-CE
Not in Commercial Distribution

  • 05055331306548 ()
NCL-MEROSIN

  • Laminin IVD, antibody
NCL-L-MESO is intended for the qualitative identification by light microscopy of Mesothelin molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
MESO-L-CE
In Commercial Distribution

  • 05055331306487 ()
NCL-L-MESO

  • Mesothelin IVD, antibody
Synaptophysin (27G12) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human synaptophysin 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
PA0299
In Commercial Distribution

  • 05055331304339 ()
PA0299

  • Synaptophysin IVD, antibody
Mesothelin (5B2) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human mesothelin 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
PA0373
In Commercial Distribution

  • 05055331304209 ()
PA0373

  • Mesothelin IVD, antibody
Fascin (IM20) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human fascin 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
PA0420
In Commercial Distribution

  • 05055331304148 ()
PA0420

  • Fascin IVD, antibody
Insulin (2D11-H5) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human insulin 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
PA0620
In Commercial Distribution

  • 05055331303912 ()
PA0620

  • Insulin IVD, antibody
Myoglobin (MYO18) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human myoglobin 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
PA0727
In Commercial Distribution

  • 05055331303875 ()
PA0727

  • Myoglobin IVD, antibody
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