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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 - 05055331334237

Cyclin D1 (EP12) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of cyclin D1 protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX system, BOND-III system and BOND-PRIME system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0046-U
In Commercial Distribution

  • 05055331334237 ()
PA0046-U

  • Cyclin D1 IVD, antibody

BOND - 05055331334220

Melan A (A103) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human melan 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
PA0044-U
In Commercial Distribution

  • 05055331334220 ()
PA0044-U

  • Melan-A/MART-1 peptide IVD, antibody

BOND - 05055331334213

CD45 (X16/99) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD45 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
PA0042-U
In Commercial Distribution

  • 05055331334213 ()
PA0042-U

  • CD45 leukocyte common antigen cell marker IVD, antibody

BOND - 05055331334206

Cytokeratin 20 (Ks20.8) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratin 20 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
PA0037-U
In Commercial Distribution

  • 05055331334206 ()
PA0037-U

  • Cytokeratin IVD, antibody

BOND™ - 05055331334190

Epithelial Membrane Antigen (GP1.4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human epithelial membrane antigen (EMA) 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
PA0035-U
In Commercial Distribution

  • 05055331334190 ()
PA0035-U

  • Epithelial membrane antigen (EMA) IVD, antibody

BOND - 05055331334183

Desmin (DE-R-11) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human desmin in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX system, BOND-III system and BOND-PRIME system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0032-U
In Commercial Distribution

  • 05055331334183 ()
PA0032-U

  • Desmin protein IVD, antibody

BOND - 05055331334176

S-100 (EP32) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of S-100B 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
PA0031-U
In Commercial Distribution

  • 05055331334176 ()
PA0031-U

  • S100-beta (S100-B) protein IVD, antibody

BOND - 05055331334169

Melanoma Marker (HMB45) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human HMB45 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
PA0027-U
In Commercial Distribution

  • 05055331334169 ()
PA0027-U

  • Melanoma specific protein IVD, antibody

BOND - 05055331334152

Glial Fibrillary Acidic Protein (GA5) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human glial fibrillary acidic protein (GFAP) 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
PA0026-U
In Commercial Distribution

  • 05055331334152 ()
PA0026-U

  • Glial fibrillary acidic protein (GFAP) IVD, antibody

BOND - 05055331334121

p16 (6H12) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human p16 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
PA0016-U
In Commercial Distribution

  • 05055331334121 ()
PA0016-U

  • p16 antigen IVD, antibody
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