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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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Muc-2 (Ccp58) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Muc-2 glycoprotein 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
PA0155-U
In Commercial Distribution

  • 05055331334503 ()
PA0155-U

  • Mucin IVD, antibody
Ki67 (MM1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of 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
PA0118-U
In Commercial Distribution

  • 05055331334428 ()
PA0118-U

  • Ki67 antigen IVD, antibody
Napsin A (IP64) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human napsin 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
PA0064-U
In Commercial Distribution

  • 05055331334312 ()
PA0064-U

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

  • 05055331334275 ()
PA0053-U

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

  • 05055331334251 ()
PA00051-U

  • Mucin 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 BOND-MAX system, BOND-III system and BOND-PRIME system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0046-U
In Commercial Distribution

  • 05055331334237 ()
PA0046-U

  • Cyclin D1 IVD, antibody
NCL-L-MSH6-U is intended for the qualitative identification by light microscopy of Mismatch Repair Protein 6 (MSH6) molecules in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
MSH6-L-U
In Commercial Distribution

  • 05055331334008 ()
NCL-L-MSH6-U

  • MSH6 antigen IVD, antibody
NCL-L-InhibinA-U is intended for the qualitative identification by light microscopy of inhibin alpha molecules in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
INHIBINA-L-U
In Commercial Distribution

  • 05055331333889 ()
NCL-L-INHIBINA-U

  • Inhibin A IVD, antibody
NCL-L-GRAN-B-U is intended for the qualitative identification by light microscopy of Granzyme B molecules in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
GRAN-B-L-U
In Commercial Distribution

  • 05055331333773 ()
NCL-L-GRAN-B-U

  • Granzyme B IVD, antibody
NCL-L-CYCLIN D1-GM-U is intended for the qualitative identification by light microscopy of Cyclin D1 molecules in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CYCLIND1-GM-L-U
In Commercial Distribution

  • 05055331333599 ()
NCL-L-CYCLIND1-GM-U

  • Cyclin D1 IVD, antibody
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