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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™ - 05055331317414

NCL-L-AMACR is intended for the qualitative identification by light microscopy of alpha-methylacyl-CoA racemase (AMACR) molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
AMACR-L-CE
In Commercial Distribution

  • 05055331317414 ()
NCL-L-AMACR

  • p504s protein IVD, antibody

Novocastra™ - 05055331317193

NCL-L-5D3 is intended for the qualitative identification by light microscopy of Cytokeratin (8/18) molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
5D3-L-CE
In Commercial Distribution

  • 05055331317193 ()
NCL-L-5D3

  • Cytokeratin IVD, antibody

Novocastra™ - 05055331317100

NCL-L-a-SARC is intended for the qualitative identification by light microscopy of Alpha-Sarcoglycan (Adhalin) by immunohistochemistry.
LEICA BIOSYSTEMS NEWCASTLE LTD
A-SARC-L-CE
Not in Commercial Distribution

  • 05055331317100 ()
NCL-L-a-SARC

  • Sarcoglycan complex IVD, antibody

Novocastra™ - 05055331316967

NCL-L-AE1/AE3 is intended for the qualitative identification by light microscopy of cytokeratin molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
AE1/AE3-L-CE
Not in Commercial Distribution

  • 05055331316967 ()
NCL-L-AE1/AE3

  • Cytokeratin IVD, antibody

Novocastra™ - 05055331316875

NCL-L-Akt-Phos is intended for the qualitative identification by light microscopy of Akt (Phosphorylated) molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
AKT-PHOS-L-CE
Not in Commercial Distribution

  • 05055331316875 ()
NCL-L-AKT-PHOS

  • Protein kinase B IVD, antibody

Novocastra™ - 05055331316424

NCL-b-DG is intended for the qualitative identification by light microscopy of Beta-Dystroglycan by immunohistochemistry.
LEICA BIOSYSTEMS NEWCASTLE LTD
B-DG-CE
Not in Commercial Distribution

  • 05055331316424 ()
NCL-b-DG

  • Beta-dystroglycan IVD, antibody

Novocastra™ - 05055331316356

NCL-L-b-SARC is intended for the qualitative identification by light microscopy of Beta-Sarcoglycan by immunohistochemistry.
LEICA BIOSYSTEMS NEWCASTLE LTD
B-SARC-L-CE
Not in Commercial Distribution

  • 05055331316356 ()
NCL-L-b-SARC

  • Sarcoglycan complex IVD, antibody

Novocastra™ - 05055331316226

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

Novocastra™ - 05055331316141

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

Novocastra™ - 05055331315816

NCL-L-CA125 is intended for the qualitative identification by light microscopy of CA125 (Ovarian Cancer Antigen) molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CA125-L-CE
In Commercial Distribution

  • 05055331315816 ()
NCL-L-CA125

  • Cancer antigen 125 (CA125) IVD, antibody
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