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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 - 05055331334206

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 BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0037-U
In Commercial Distribution

  • 05055331334206 ()
PA0037-U

  • Cytokeratin IVD, antibody

BOND™ - 05055331334190

Epithelial Membrane Antigen (GP1.4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human epithelial membrane antigen (EMA) in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0035-U
In Commercial Distribution

  • 05055331334190 ()
PA0035-U

  • Epithelial membrane antigen (EMA) IVD, antibody

BOND - 05055331334183

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 BOND-MAX system, BOND-III system and BOND-PRIME system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0032-U
In Commercial Distribution

  • 05055331334183 ()
PA0032-U

  • Desmin protein IVD, antibody

BOND - 05055331334176

S-100 (EP32) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of S-100B protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system ( (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0031-U
In Commercial Distribution

  • 05055331334176 ()
PA0031-U

  • S100-beta (S100-B) protein IVD, antibody

BOND - 05055331334169

Melanoma Marker (HMB45) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human HMB45 antigen in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0027-U
In Commercial Distribution

  • 05055331334169 ()
PA0027-U

  • Melanoma specific protein IVD, antibody

BOND - 05055331334152

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 (GFAP) in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0026-U
In Commercial Distribution

  • 05055331334152 ()
PA0026-U

  • Glial fibrillary acidic protein (GFAP) IVD, antibody

BOND - 05055331334121

p16 (6H12) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human p16 protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0016-U
In Commercial Distribution

  • 05055331334121 ()
PA0016-U

  • p16 antigen IVD, antibody

BOND™ - 05055331334114

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

  • 05055331334114 ()
PA0014-U

  • Human chorionic gonadotropin beta-subunit IVD, antibody

BOND™ - 05055331334107

Estrogen Receptor Clone 6F11 Ready-To-Use Primary Antibody For BOND monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human estrogen receptor (ER) 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
PA0009-U
In Commercial Distribution

  • 05055331334107 ()
PA0009-U

  • Estrogen (oestrogen)/progesterone receptor IVD, antibody

BOND - 05055331334091

CD117 (EP10) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD117 (c-kit) oncoprotein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX system, BOND-III system and BOND-PRIME system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0007-U
In Commercial Distribution

  • 05055331334091 ()
PA0007-U

  • CD117 (c-kit) cell marker IVD, antibody
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