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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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Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0552
In Commercial Distribution

  • 05055331303998 ()
PA0552

  • B-cell specific activator protein (BSAP) IVD, antibody
CD3 (LN10) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD3 molecule in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BONDMAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0553
In Commercial Distribution

  • 05055331303981 ()
PA0553

  • CD3 cell marker IVD, antibody
CD11c (5D11) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD11c antigen in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0554
In Commercial Distribution

  • 05055331303974 ()
PA0554

  • CD11c cell marker IVD, antibody
CD33 (PWS44) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD33 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0555
In Commercial Distribution

  • 05055331303967 ()
PA0555

  • CD33 cell marker IVD, antibody
B Cell Specific Octamer Binding Protein-1 (TG14) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human B cell specific octamer binding protein-1 (BOB-1) in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0558
In Commercial Distribution

  • 05055331303950 ()
PA0558

  • B-cell specific octamer binding protein-1 (BOB-1) IVD, antibody
Wilms’ Tumor (WT49) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Wilms’ Tumor WT1 gene product. in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0562
In Commercial Distribution

  • 05055331303943 ()
PA0562

  • Wilms tumour protein IVD, antibody
Cytokeratin 8 (TS1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratin 8 intermediate filament. in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0567
In Commercial Distribution

  • 05055331303936 ()
PA0567

  • Cytokeratin IVD, antibody
Insulin (2D11-H5) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human insulin in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0620
In Commercial Distribution

  • 05055331303912 ()
PA0620

  • Insulin IVD, antibody
Human Follicle Stimulating Hormone (INN-hFSH-60) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human follicle stimulating hormone in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0693
In Commercial Distribution

  • 05055331303899 ()
PA0693

  • Follicle stimulating hormone (FSH) IVD, antibody
Human Growth Hormone (Polyclonal) antibody is intended to be used for the qualitative identification by light microscopy of human growth hormone in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0704
In Commercial Distribution

  • 05055331303882 ()
PA0704

  • Human growth hormone (HGH) IVD, antibody
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