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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™ - 05055331304216

Neurofilament 200 kD (N52.1.7) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of the NF-H (200 kD) subunit of human neurofilament 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
PA0371
In Commercial Distribution

  • 05055331304216 ()
PA0371

  • Neurofilament protein IVD, antibody

BOND™ - 05055331304209

Mesothelin (5B2) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human mesothelin 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
PA0373
In Commercial Distribution

  • 05055331304209 ()
PA0373

  • Mesothelin IVD, antibody

BOND™ - 05055331304193

E-Cadherin (36B5) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human E-cadherin in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an automated BOND system (includes Leica BONDMAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0387
In Commercial Distribution

  • 05055331304193 ()
PA0387

  • Cadherin protein IVD, antibody

BOND™ - 05055331304186

Muramidase (Lysozyme) (Polyclonal) antibody is intended to be used for the qualitative identification by light microscopy of human muramidase (lysozyme) 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
PA0391
In Commercial Distribution

  • 05055331304186 ()
PA0391

  • Lysozyme (muramidase) IVD, antibody

BOND™ - 05055331304179

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
PA0400
Not in Commercial Distribution

  • 05055331304179 ()
PA0400

  • Coagulation factor VIII-associated antigen IVD, antibody

BOND™ - 05055331304155

Calponin (Basic) (26A11) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human calponin 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
PA0416
In Commercial Distribution

  • 05055331304155 ()
PA0416

  • Calponin protein IVD, antibody

BOND™ - 05055331304148

Fascin (IM20) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human fascin 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
PA0420
In Commercial Distribution

  • 05055331304148 ()
PA0420

  • Fascin IVD, antibody

BOND™ - 05055331304131

CA19-9 (Sialyl Lewisa) (C241:5:1:4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of Sialyl Lewisa 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
PA0424
In Commercial Distribution

  • 05055331304131 ()
PA0424

  • Cancer antigen 19-9 (CA19-9) GI IVD, antibody

BOND™ - 05055331304124

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
PA0430
In Commercial Distribution

  • 05055331304124 ()
PA0430

  • Chromogranin A IVD, antibody

BOND™ - 05055331304117

Prostate Specific Antigen (35H9) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human prostate specific 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
PA0431
In Commercial Distribution

  • 05055331304117 ()
PA0431

  • Prostate-specific membrane antigen (PSMA) IVD, antibody
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