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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 - 05055331335142

Cytokeratin 5 (XM26) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratin 5 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
PA0468-U
In Commercial Distribution

  • 05055331335142 ()
PA0468-U

  • Cytokeratin IVD, antibody

BOND™ - 05055331335135

Factor XIIIa (E980.1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human blood coagulation factor XIIIa 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
PA0449-U
In Commercial Distribution

  • 05055331335135 ()
PA0449-U

  • Coagulation factor XIIIa pro-enzyme subunit IVD, antibody

BOND™ - 05055331335128

Muc-4 Glycoprotein (EPR9308) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Muc-4 glycoprotein 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
PA0444-U
In Commercial Distribution

  • 05055331335128 ()
PA0444-U

  • Mucin IVD, antibody

BOND™ - 05055331335111

CD57 (NK-1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD57 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
PA0443-U
In Commercial Distribution

  • 05055331335111 ()
PA0443-U

  • CD57 natural killer cell marker IVD, antibody

BOND™ - 05055331335104

BOND Ready-to-Use Primary Antibody Progesterone Receptor (16) is a monoclonal antibody intended to be used for the qualitative identification by light microscopy of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX or BOND-III systems. Progesterone Receptor Clone (16) specifically binds to the progesterone receptor antigen located in the nucleus of progesterone receptor positive normal and neoplastic cells.
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0436-U
In Commercial Distribution

  • 05055331335104 ()
PA0436-U

  • Estrogen (oestrogen)/progesterone receptor IVD, antibody

BOND™ - 05055331335098

Neuron Specific Enolase (22C9) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human neuron specific enolase 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
PA0435-U
In Commercial Distribution

  • 05055331335098 ()
PA0435-U

  • Neuron-specific enolase (NSE) IVD, antibody

BOND - 05055331335081

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 BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0431-U
In Commercial Distribution

  • 05055331335081 ()
PA0431-U

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

BOND - 05055331335074

CD4 (4B12) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD4 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
PA0427-U
In Commercial Distribution

  • 05055331335074 ()
PA0427-U

  • CD4 cell marker IVD, antibody

BOND™ - 05055331335067

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

  • 05055331335067 ()
PA0424-U

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

BOND™ - 05055331335050

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

  • 05055331335050 ()
PA0420-U

  • Fascin IVD, antibody
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