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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™ - 05055331335258

CD33 (PWS44) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD33 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
PA0555-U
In Commercial Distribution

  • 05055331335258 ()
PA0555-U

  • CD33 cell marker IVD, antibody

BOND - 05055331335241

CD11c (5D11) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD11c 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
PA0554-U
In Commercial Distribution

  • 05055331335241 ()
PA0554-U

  • CD11c cell marker IVD, antibody

BOND - 05055331335234

CD3 (LN10) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD3 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
PA0553-U
In Commercial Distribution

  • 05055331335234 ()
PA0553-U

  • CD3 cell marker IVD, antibody

BOND - 05055331335227

Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 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
PA0552-U
In Commercial Distribution

  • 05055331335227 ()
PA0552-U

  • B-cell specific activator protein (BSAP) IVD, antibody

BOND - 05055331335210

CA125 (Ovarian Cancer Antigen)(Ov185:1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of repetitive protein determinant expressed in the protein core of the CA125 human ovarian cancer 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
PA0539-U
In Commercial Distribution

  • 05055331335210 ()
PA0539-U

  • Cancer antigen 125 (CA125) IVD, antibody

BOND™ - 05055331335203

Oct-2 (Oct-207) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Oct-2 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
PA0532-U
In Commercial Distribution

  • 05055331335203 ()
PA0532-U

  • Oct-2 IVD, antibody

BOND - 05055331335197

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 BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0515-U
In Commercial Distribution

  • 05055331335197 ()
PA0515-U

  • Chromogranin A IVD, antibody

BOND™ - 05055331335180

Myosin Heavy Chain (smooth muscle) (S131) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human myosin heavy chain (smooth muscle) 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
PA0493-U
In Commercial Distribution

  • 05055331335180 ()
PA0493-U

  • Smooth muscle myosin IVD, antibody

BOND™ - 05055331335166

Inhibin Alpha (R1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human inhibin alpha 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
PA0488-U
In Commercial Distribution

  • 05055331335166 ()
PA0448-U

  • Inhibin A IVD, antibody

BOND - 05055331335159

CD15 (MMA) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD15 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
PA0473-U
In Commercial Distribution

  • 05055331335159 ()
PA0473-U

  • CD15 cell marker IVD, antibody
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