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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-AR-318 is intended for the qualitative identification by light microscopy of androgen receptor protein in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
AR-318-L-CE
In Commercial Distribution

  • 05055331328403 ()
NCL-L-AR-318

  • Androgen receptor IVD, antibody
Muc-6 Glycoprotein (CLH5) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of Muc-6 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
PA0053
In Commercial Distribution

  • 05055331328304 ()
PA0053

  • Mucin 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
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
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
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-AFP is intended for the qualitative identification by light microscopy of human alpha fetoprotein in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
AFP-L-CE
In Commercial Distribution

  • 05055331326447 ()
NCL-L-AFP

  • Alpha-fetoprotein (AFP) IVD, antibody
Cyclin D1 (EP12) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of cyclin D1 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
PA0046
In Commercial Distribution

  • 05055331326201 ()
PA0046

  • Cyclin D1 IVD, antibody
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