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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™ - 05055331334718

CD22 (FPC1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD22 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
PA0249-U
In Commercial Distribution

  • 05055331334718 ()
PA0249-U

  • CD22 cell marker IVD, antibody

BOND™ - 05055331334701

Galectin-3 (9C4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human galectin-3 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
PA0238-U
In Commercial Distribution

  • 05055331334701 ()
PA0238-U

  • Galectin-3 IVD, antibody

BOND - 05055331334695

CD1a (MTB1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD1a 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
PA0235-U
In Commercial Distribution

  • 05055331334695 ()
PA0235-U

  • CD1a cell marker IVD, antibody

BOND - 05055331334688

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
PA0233-U
In Commercial Distribution

  • 05055331334688 ()
PA0233-U

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

BOND™ - 05055331334671

Ki67 (K2) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of the human Ki67 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
PA0230-U
In Commercial Distribution

  • 05055331334671 ()
PA0230-U

  • Ki67 antigen IVD, antibody

BOND™ - 05055331334664

Myf-4 (Rhabdomyosarcoma Marker) (LO26) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Myf-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
PA0226-U
In Commercial Distribution

  • 05055331334664 ()
PA0226-U

  • Myogenin IVD, antibody

BOND - 05055331334657

DOG-1 (K9) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human DOG-1 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
PA0219-U
In Commercial Distribution

  • 05055331334657 ()
PA0219-U

  • Anoctamin-1 (ANO1) IVD, antibody

BOND™ - 05055331334640

PD-1 (CAL20) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human PD-1 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
PA0216-U
In Commercial Distribution

  • 05055331334640 ()
PA0216-U

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

BOND - 05055331334633

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

BOND - 05055331334626

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
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