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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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Novocastra™ - 05055331310354

NCL-DYS3 is intended for the qualitative identification by light microscopy of Dystrophin (N-terminus) by immunohistochemistry.
LEICA BIOSYSTEMS NEWCASTLE LTD
DYS3-CE
Not in Commercial Distribution

  • 05055331310354 ()
NCL-DYS3

  • Dystrophin IVD, antibody

Novocastra™ - 05055331309846

NCL-EMERIN is intended for the qualitative identification by light microscopy of Emerin by immunohistochemistry.
LEICA BIOSYSTEMS NEWCASTLE LTD
EMERIN-CE
Not in Commercial Distribution

  • 05055331309846 ()
NCL-EMERIN

  • Emerin IVD, antibody

Novocastra™ - 05055331308825

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

Novocastra™ - 05055331308528

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

Novocastra™ - 05055331308511

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

Novocastra™ - 05055331306548

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

Novocastra™ - 05055331306487

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

BOND™ - 05055331303912

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

Novocastra™ - 05055331301482

NCL-SPEC1 is intended for the qualitative identification by light microscopy of Spectrin by immunohistochemistry.
LEICA BIOSYSTEMS NEWCASTLE LTD
SPEC1-CE
Not in Commercial Distribution

  • 05055331301482 ()
NCL-SPEC1

  • Spectrin IVD, antibody

Novocastra™ - 05055331301352

NCL-L-SYNAP-299 is intended for the qualitative identification by light microscopy of Synaptophysin molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
SYNAP-299-L-CE
In Commercial Distribution

  • 05055331301352 ()
NCL-L-SYNAP-299

  • Synaptophysin IVD, antibody
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