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

  • 05055331335753 ()
NCL-L-PTH-488-U

  • Parathyroid hormone (PTH) IVD, antibody
NCL-L-PSA-431-U is intended for the qualitative identification by light microscopy of human prostate specific antigen in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
PSA-431-L-U
In Commercial Distribution

  • 05055331335746 ()
NCL-L-PSA-431-U

  • Prostate-specific membrane antigen (PSMA) IVD, antibody
NCL-L-PMS2-U is intended for the qualitative identification by light microscopy of PMS2 molecules in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
PMS2-L-U
In Commercial Distribution

  • 05055331335715 ()
NCL-L-PMS2-U

  • Postmeiotic segregation increased 2 (PMS2) IVD, antibody
NCL-L-PLAP-8A9-U is intended for the qualitative identification by light microscopy of Placental Alkaline Phosphatase molecules in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
PLAP-8A9-L-U
In Commercial Distribution

  • 05055331335708 ()
NCL-L-PLAP-8A9-U

  • Human placental alkaline phosphatase (hPLAP) IVD, antibody
NCL-L-PGP9.5-U is intended for the qualitative identification by light microscopy of Protein Gene Product 9.5 molecules in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
PGP9.5-L-U
In Commercial Distribution

  • 05055331335678 ()
NCL-L-PGP9.5-U

  • Protein gene product 9.5 (PGP9.5) IVD, antibody
NCL-L-PAX-5-U is intended for the qualitative identification by light microscopy of human Pax-5 in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
PAX5-L-U
In Commercial Distribution

  • 05055331335562 ()
NCL-L-PAX-5-U

  • B-cell specific activator protein (BSAP) IVD, antibody
Alpha Fetoprotein (C3) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human alpha fetoprotein 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
PA0963-U
In Commercial Distribution

  • 05055331335548 ()
PA0963-U

  • Alpha-fetoprotein (AFP) IVD, antibody
Smooth Muscle Actin (alpha sm-1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human alpha smooth muscle actin 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
PA0943-U
In Commercial Distribution

  • 05055331335531 ()
PA0943-U

  • Smooth muscle actin IVD, antibody
Cytokeratin 7 (RN7) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratin 7 intermediate filament 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
PA0942-U
In Commercial Distribution

  • 05055331335524 ()
PA0942-U

  • Cytokeratin IVD, antibody
Carcinoembryonic Antigen (CD66e) (COL-1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human carcinoembryonic antigen (CEA) 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
PA0848-U
In Commercial Distribution

  • 05055331335487 ()
PA0848-U

  • Carcinoembryonic antigen (CEA) IVD, antibody
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