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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™ - 05055331326423

NCL-L-CD71-309 is intended for the qualitative identification by light microscopy of human CD71 molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD71-309-L-CE
In Commercial Distribution

  • 05055331326423 ()
NCL-L-CD71-309

  • CD71 cell marker IVD, antibody

Novocastra™ - 05055331326416

NCL-L-CK17 is intended for the qualitative identification by light microscopy of human cytokeratin 17 intermediate filament protein in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CK17-L-CE
In Commercial Distribution

  • 05055331326416 ()
NCL-L-CK17

  • Cytokeratin IVD, antibody

BOND™ - 05055331326300

Enhancer of Zeste Homolog 2 (Drosophila) (EZH2) (6A10) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human EZH2 antigen 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
PA0575
Not in Commercial Distribution

  • 05055331326300 ()
PA0575

  • Enhancer of zeste homolog 2 (EZH2) IVD, antibody

BOND™ - 05055331326201

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 Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0046
In Commercial Distribution

  • 05055331326201 ()
PA0046

  • Cyclin D1 IVD, antibody

BOND™ - 05055331326027

von Willebrand Factor (36B11) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human von Willebrand Factor 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
PA0055
In Commercial Distribution

  • 05055331326027 ()
PA0055

  • Coagulation factor VIII-associated antigen IVD, antibody

BOND™ - 05055331326003

CD13 (38C12) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD13 antigen 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
PA0304
In Commercial Distribution

  • 05055331326003 ()
PA0304

  • CD13 cell marker IVD, antibody

BOND™ - 05055331325945

Oct-3/4 (N1NK) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of Oct-3/4 antigen 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
PA0193
In Commercial Distribution

  • 05055331325945 ()
PA0193

  • Oct-3/4 IVD, antibody

BOND™ - 05055331325921

Muc-2 (Ccp58) antibody is intended to be used for the qualitative identification by light microscopy of Muc-2 glycoprotein 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
PA0155
In Commercial Distribution

  • 05055331325921 ()
PA0155

  • Mucin IVD, antibody

BOND™ - 05055331325907

Chromogranin A (5H7) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human chromogranin A 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
PA0515
In Commercial Distribution

  • 05055331325907 ()
PA0515

  • Chromogranin A IVD, antibody

Novocastra™ - 05055331325808

NCL-L-CD31-607 is intended for the qualitative identification by light microscopy of human CD31 (PECAM-1) molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD31-607-L-CE
In Commercial Distribution

  • 05055331325808 ()
NCL-L-CD31-607

  • CD31 endothelial cell marker IVD, antibody
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