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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 - 05055331334336

Cytokeratin 14 (LL002) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratin 14 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
PA0074-U
In Commercial Distribution

  • 05055331334336 ()
PA0074-U

  • Cytokeratin IVD, antibody

BOND™ - 05055331334329

Cytokeratin 8/18 (5D3) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratin 8 and 18 (CK8/18) intermediate filaments 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
PA0067-U
In Commercial Distribution

  • 05055331334329 ()
PA0067-U

  • Cytokeratin IVD, antibody

BOND - 05055331334312

Napsin A (IP64) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human napsin 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
PA0064-U
In Commercial Distribution

  • 05055331334312 ()
PA0064-U

  • Napsin A IVD, antibody

BOND - 05055331334305

Immunoglobulin D (DRN1C) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Immunoglobulin D 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
PA0061-U
In Commercial Distribution

  • 05055331334305 ()
PA0061-U

  • Total immunoglobulin D (IgD total) IVD, antibody

BOND - 05055331334299

p53 (DO-7) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human p53 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
PA0057-U
In Commercial Distribution

  • 05055331334299 ()
PA0057-U

  • p53 tumour protein IVD, antibody

BOND - 05055331334282

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 BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0055-U
In Commercial Distribution

  • 05055331334282 ()
PA0055-U

  • Coagulation factor VIII-associated antigen IVD, antibody

BOND™ - 05055331334275

Muc-6 Glycoprotein (CLH5) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Muc-6 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
PA0053-U
In Commercial Distribution

  • 05055331334275 ()
PA0053-U

  • Mucin IVD, antibody

BOND™ - 05055331334268

Muc-5AC Glycoprotein (CLH2) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Muc-5AC 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
PA0052-U
In Commercial Distribution

  • 05055331334268 ()
PA0052-U

  • Mucin IVD, antibody

BOND™ - 05055331334251

Muc-1 Glycoprotein (Ma695) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Muc-1 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
PA0051-U
In Commercial Distribution

  • 05055331334251 ()
PA00051-U

  • Mucin IVD, antibody

BOND - 05055331334244

Human Herpesvirus (Type 8) (13B10) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human herpesvirus (Type 8) (latent nuclear 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
PA0050-U
In Commercial Distribution

  • 05055331334244 ()
PA0050-U

  • Human herpesvirus 8 (HHV8) antigen IVD, antibody
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