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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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Immunoglobulin G (RWP49) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of immunoglobulin G 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
PA0905
In Commercial Distribution

  • 05055331326836 ()
PA0905

  • Total immunoglobulin G (IgG total) IVD, antibody
CD15 (MMA) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD15 protein 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
PA0473
In Commercial Distribution

  • 05055331326829 ()
PA0473

  • CD15 cell marker IVD, antibody
Carcinoembryonic Antigen (CD66e) (COL-1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of carcinoembryonic 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
PA0848
In Commercial Distribution

  • 05055331326812 ()
PA0848

  • Carcinoembryonic antigen (CEA) IVD, antibody
CD79a (JCB117) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD79a protein 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
PA0599
Not in Commercial Distribution

  • 05055331326805 ()
PA0599

  • CD79a cell marker IVD, antibody
p40 (BC28) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of p40 protein 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
PA0163
In Commercial Distribution

  • 05055331326515 ()
PA0163

  • p40 protein IVD, antibody
Alpha-Methylacyl-CoA Racemase (EPMU1) antibody is intended to be used for the qualitative identification by light microscopy of alpha-methylacyl-CoA racemase molecules 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
PA0210
In Commercial Distribution

  • 05055331326492 ()
PA0210

  • p504s protein IVD, antibody
Napsin A (IP64) antibody is intended to be used for the qualitative identification by light microscopy of napsin A molecules 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
PA0064
In Commercial Distribution

  • 05055331326485 ()
PA0064

  • Napsin A IVD, antibody
NCL-L-CHROM-430 is intended for the qualitative identification by light microscopy of chromogranin A molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CHROM-430-L-CE
In Commercial Distribution

  • 05055331326478 ()
NCL-L-CHROM-430

  • Chromogranin A IVD, antibody
NCL-L-CD16 is intended for the qualitative identification by light microscopy of human CD16 antigen in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD16-L-CE
In Commercial Distribution

  • 05055331326461 ()
NCL-L-CD16

  • CD16 cell marker IVD, antibody
NCL-L-B-CAT is intended for the qualitative identification by light microscopy of human beta-catenin in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
B-CAT-L-CE
In Commercial Distribution

  • 05055331326454 ()
NCL-L-B-CAT

  • Beta-catenin IVD, antibody
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