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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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NCL-L-PTH-488 is intended for the qualitative identification by light microscopy of human parathyroid hormone in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
PTH-488-L-CE
In Commercial Distribution

  • 05055331328243 ()
NCL-L-PTH-488

  • Parathyroid hormone (PTH) IVD, antibody
NCL-L-LANGERIN is intended for the qualitative identification by light microscopy of human langerin in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
LANGERIN-L-CE
In Commercial Distribution

  • 05055331328236 ()
NCL-L-LANGERIN

  • CD207 cell marker IVD, antibody
NCL-L-p57 is intended for the qualitative identification by light microscopy of human p57protein, also known as Kip2 protein, in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
P57-L-CE
In Commercial Distribution

  • 05055331328229 ()
NCL-L-p57

  • P57 protein IVD, antibody
Muc-5AC Glycoprotein (CLH2) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of Muc-5AC Glycoprotein 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
PA0052
In Commercial Distribution

  • 05055331328212 ()
PA0052

  • Mucin IVD, antibody
Muc-1 Glycoprotein (Ma695) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of Muc-1 Glycoprotein 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
PA0051
In Commercial Distribution

  • 05055331328205 ()
PA0051

  • Mucin IVD, antibody
c-erbB-2 Oncoprotein (CB11) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of c-erbB-2 oncoprotein 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
PA0983
In Commercial Distribution

  • 05055331328007 ()
PA0983

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody
c-erbB-2 Oncoprotein (CB11) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of c-erbB-2 oncoprotein 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
PA0571
In Commercial Distribution

  • 05055331327901 ()
PA0571

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody
Inhibin Alpha (R1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human inhibin alpha 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
PA0488
In Commercial Distribution

  • 05055331327000 ()
PA0488

  • Inhibin A IVD, antibody
NCL-L-CEA-609 is intended for the qualitative identification by light microscopy of carcinoembryonic antigen in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CEA-609-L-CE
In Commercial Distribution

  • 05055331326850 ()
NCL-L-CEA-609

  • Carcinoembryonic antigen (CEA) IVD, antibody
NCL-L-AE1/AE3-601 is intended for the qualitative identification by light microscopy of human cytokeratins 56.5, 50, 50’, 48 and 40 kD of the acidic subfamily and 65 to 67, 64, 59, 58, 56 and 52 kD of the basic subfamily in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
AE1/AE3-601-L-CE
In Commercial Distribution

  • 05055331326843 ()
NCL-L-AE1/AE3-601

  • Cytokeratin IVD, antibody
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