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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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Gross Cystic Disease Fluid Protein-15 (23A3) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human gross cystic disease fluid protein (15 kD) 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
PA0708
In Commercial Distribution

  • 05055331321572 ()
PA0708

  • Gross cystic disease fluid protein-15 IVD, antibody
p63 (7JUL) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human p63 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
PA0103
In Commercial Distribution

  • 05055331321565 ()
PA0103

  • p63 tumour protein IVD, antibody
Cytokeratin 20 (Ks20.8) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratin 20 intermediate filament 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
PA0037
In Commercial Distribution

  • 05055331321558 ()
PA0037

  • Cytokeratin IVD, antibody
Cytokeratin 20 (Ks20.8) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratin 20 intermediate filament 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
PA0022
In Commercial Distribution

  • 05055331321541 ()
PA0022

  • Cytokeratin IVD, antibody
NCL-L-LANGERIN-U is intended for the qualitative identification by light microscopy of human langerin in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
LANGERIN-L-U
In Commercial Distribution

  • 05055331321435 ()
NCL-L-LANGERIN-U

  • CD207 cell marker IVD, antibody
NCL-L-CD71-309-U is intended for the qualitative identification by light microscopy of human CD71 molecules in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD71-309-L-U
In Commercial Distribution

  • 05055331321428 ()
NCL-L-CD71-309-U

  • CD71 cell marker IVD, antibody
NCL-L-GSTpi-438 is intended for the qualitative identification by light microscopy of human glutathione S-transferase pi in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
GSTPI-438-L-U
In Commercial Distribution

  • 05055331321411 ()
NCL-L-GSTpi-438

  • Pi-glutathione S-transferase (pi-GST) IVD, antibody
NCL-L-CD13-304-U is intended for the qualitative identification by light microscopy of human CD13 antigen in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD13-304-L-U
In Commercial Distribution

  • 05055331321374 ()
NCL-L-CD13-304-U

  • CD13 cell marker IVD, antibody
NCL-L-MyoD1 is intended for the qualitative identification by light microscopy of mouse MyoD1 protein in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
MYOD1-L-U
In Commercial Distribution

  • 05055331321350 ()
NCL-L-MyoD1

  • Myo-D1 protein rhabdomyosarcoma marker IVD, antibody
NCL-L-TH is intended for the qualitative identification by light microscopy of human tyrosine hydroxylase in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
TH-L-U
In Commercial Distribution

  • 05055331321343 ()
NCL-L-TH

  • Tyrosine hydroxylase IVD, antibody
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