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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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BOND™ - 05055331304773

Prostatic Acid Phosphatase (PASE/4LJ) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human prostatic acid phosphatase 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
PA0006
In Commercial Distribution

  • 05055331304773 ()
PA0006

  • Prostatic acid phosphatase (PAP) IVD, antibody

BOND™ - 05055331304766

Human Chorionic Gonadotrophin (Polyclonal) antibody is intended to be used for the qualitative identification by light microscopy of human chorionic gonadotrophin in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0014
In Commercial Distribution

  • 05055331304766 ()
PA0014

  • Human chorionic gonadotropin beta-subunit IVD, antibody

BOND™ - 05055331304759

Mast Cell Tryptase (10D11) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human mast cell tryptase in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0019
In Commercial Distribution

  • 05055331304759 ()
PA0019

  • Mast cell protease IVD, antibody

BOND™ - 05055331304735

Glial Fibrillary Acidic Protein (GA5) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human glial fibrillary acidic 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
PA0026
In Commercial Distribution

  • 05055331304735 ()
PA0026

  • Glial fibrillary acidic protein (GFAP) IVD, antibody

BOND™ - 05055331304728

Desmin (DE-R-11) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human desmin 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
PA0032
In Commercial Distribution

  • 05055331304728 ()
PA0032

  • Desmin protein IVD, antibody

BOND™ - 05055331304704

Epithelial Membrane Antigen (GP1.4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human epithelial membrane 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
PA0035
In Commercial Distribution

  • 05055331304704 ()
PA0035

  • Epithelial membrane antigen (EMA) IVD, antibody

BOND™ - 05055331304681

CD45 (X16/99) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD45 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
PA0042
In Commercial Distribution

  • 05055331304681 ()
PA0042

  • CD45 leukocyte common antigen cell marker IVD, antibody

BOND™ - 05055331304674

MSH2 (Mismatch Repair Protein) (25D12) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human MSH2 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
PA0048
Not in Commercial Distribution

  • 05055331304674 ()
PA0048

  • MSH2 antigen IVD, antibody

BOND™ - 05055331304667

p53 (DO-7) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human p53 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
PA0057
In Commercial Distribution

  • 05055331304667 ()
PA0057

  • p53 tumour protein IVD, antibody

BOND™ - 05055331304650

Cytokeratin 8/18 (5D3) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratin 8 and 18 intermediate filaments 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
PA0067
In Commercial Distribution

  • 05055331304650 ()
PA0067

  • Cytokeratin IVD, antibody
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