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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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Novocastra - 05055331335562

NCL-L-PAX-5-U is intended for the qualitative identification by light microscopy of human Pax-5 in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
PAX5-L-U
In Commercial Distribution

  • 05055331335562 ()
NCL-L-PAX-5-U

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

BOND™ - 05055331335548

Alpha Fetoprotein (C3) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human alpha fetoprotein 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
PA0963-U
In Commercial Distribution

  • 05055331335548 ()
PA0963-U

  • Alpha-fetoprotein (AFP) IVD, antibody

BOND - 05055331335531

Smooth Muscle Actin (alpha sm-1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human alpha smooth muscle actin 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
PA0943-U
In Commercial Distribution

  • 05055331335531 ()
PA0943-U

  • Smooth muscle actin IVD, antibody

BOND - 05055331335524

Cytokeratin 7 (RN7) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratin 7 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
PA0942-U
In Commercial Distribution

  • 05055331335524 ()
PA0942-U

  • Cytokeratin IVD, antibody

BOND - 05055331335487

Carcinoembryonic Antigen (CD66e) (COL-1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human carcinoembryonic antigen (CEA) 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
PA0848-U
In Commercial Distribution

  • 05055331335487 ()
PA0848-U

  • Carcinoembryonic antigen (CEA) IVD, antibody

BOND - 05055331335463

Programmed Death Ligand 1 (73-10) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of PD-L1 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
PA0832-U
In Commercial Distribution

  • 05055331335463 ()
PA0832-U

  • Programmed death-ligand 1 (PD-L1) IVD, antibody

BOND - 05055331335456

Anaplastic Lymphoma Kinase (5A4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of ALK and ALK fusion proteins 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
PA0831-U
In Commercial Distribution

  • 05055331335456 ()
PA0831-U

  • Anaplastic lymphoma kinase IVD, antibody

BOND - 05055331335432

CD30 (JCM182) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD30 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
PA0790-U
In Commercial Distribution

  • 05055331335432 ()
PA0790-U

  • Tumour necrosis factor receptor superfamily IVD, antibody

BOND™ - 05055331335395

Myoglobin (MYO18) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human myoglobin 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
PA0727-U
In Commercial Distribution

  • 05055331335395 ()
PA0727-U

  • Myoglobin IVD, antibody

BOND - 05055331335340

Vimentin (V9) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human vimentin 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
PA0640-U
In Commercial Distribution

  • 05055331335340 ()
PA0640-U

  • Vimentin IVD, antibody
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