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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™ - 05055331334862

Tyrosinase (T311) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human tyrosinase 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
PA0322-U
In Commercial Distribution

  • 05055331334862 ()
PA0322-U

  • Tyrosinase IVD, antibody

BOND™ - 05055331334848

CD61 (2f2) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD61 protein (GPIIIa) 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
PA0308-U
In Commercial Distribution

  • 05055331334848 ()
PA0308-U

  • CD61 platelet glycoprotein IIIa marker IVD, antibody

BOND™ - 05055331334831

CD25 (4C9) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human interleukin-2 receptor alpha chain (CD25) 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
PA0305-U
In Commercial Distribution

  • 05055331334831 ()
PA0305-U

  • CD25 cell marker IVD, antibody

BOND™ - 05055331334824

LAG-3 (12H6) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human LAG-3 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
PA0300-U
In Commercial Distribution

  • 05055331334824 ()
PA0300-U

  • CD223 cell marker IVD, antibody

BOND™ - 05055331334817

Synaptophysin (27G12) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human synaptophysin 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
PA0299-U
In Commercial Distribution

  • 05055331334817 ()
PA0299-U

  • Synaptophysin IVD, antibody

BOND™ - 05055331334800

Granzyme B (11F1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human granzyme B 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
PA0291-U
In Commercial Distribution

  • 05055331334800 ()
PA0291-U

  • Granzyme B IVD, antibody

BOND™ - 05055331334794

Protein Gene Product 9.5 (10A1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human protein gene product 9.5 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
PA0286-U
In Commercial Distribution

  • 05055331334794 ()
PA0286-U

  • Protein gene product 9.5 (PGP9.5) IVD, antibody

BOND - 05055331334787

Immunoglobulin M (8H6) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of immunoglobulin M (IgM) 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
PA0278-U
In Commercial Distribution

  • 05055331334787 ()
PA0278-U

  • Total immunoglobulin M (IgM total) IVD, antibody

BOND - 05055331334770

CD68 (514H12) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD68 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
PA0273-U
In Commercial Distribution

  • 05055331334770 ()
PA0273-U

  • CD68 cell marker IVD, antibody

BOND™ - 05055331334763

CD2 (11F11) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD2 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
PA0271-U
In Commercial Distribution

  • 05055331334763 ()
PA0271-U

  • CD2 T-cell marker IVD, antibody
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