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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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CD34 (QBEnd/10) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human endothelial cell marker (CD34) 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
PA0212-U
In Commercial Distribution

  • 05055331334633 ()
PA0212-U

  • CD34 cell marker IVD, antibody
Alpha-Methylacyl-CoA Racemase (EPMU1) antibody is intended to be used for the qualitative identification by light microscopy of human alphamethylacyl-CoA racemase (AMACR) 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
PA0210-U
In Commercial Distribution

  • 05055331334626 ()
PA0210-U

  • p504s protein IVD, antibody
Bcl-6 (LN22) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Bcl-6 oncoprotein 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
PA0204-U
In Commercial Distribution

  • 05055331334619 ()
PA0204-U

  • Bcl-6 protein IVD, antibody
CD20 (L26) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD20 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
PA0200-U
In Commercial Distribution

  • 05055331334602 ()
PA0200-U

  • CD20 cell marker IVD, antibody
Oct-3/4 (N1NK) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Oct-3/4 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
PA0193-U
In Commercial Distribution

  • 05055331334596 ()
PA0193-U

  • Oct-3/4 IVD, antibody
CD56 (CD564) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD56 antigen (neural cell adhesion molecules) 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
PA0191-U
In Commercial Distribution

  • 05055331334589 ()
PA0191-U

  • CD56 neural cell adhesion molecule-1 (NCAM-1) IVD, antibody
CD8 (4B11) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD8 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
PA0183-U
In Commercial Distribution

  • 05055331334572 ()
PA0183-U

  • CD8 cell marker IVD, antibody
CTLA-4 (CAL49) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CTLA-4 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
PA0181-U
In Commercial Distribution

  • 05055331334565 ()
PA0181-U

  • CD152 cell marker IVD, antibody
CD21 (2G9) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD21 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
PA0171-U
In Commercial Distribution

  • 05055331334558 ()
PA0171-U

  • CD21 cell marker IVD, antibody
CD23 (1B12) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD23 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
PA0169-U
In Commercial Distribution

  • 05055331334541 ()
PA0169-U

  • CD23 cell marker IVD, antibody
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