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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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Progesterone Receptor (PGR) Clone 16 monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining.
LEICA BIOSYSTEMS NEWCASTLE LTD
PGR-312-L-F
In Commercial Distribution

  • 05055331303158 ()
NCL-L-PGR-312

  • Estrogen (oestrogen)/progesterone receptor IVD, antibody
NCL-L-PLAP-8A9 is intended for the qualitative identification by light microscopy of Placental Alkaline Phosphatase molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
PLAP-8A9-L-CE
In Commercial Distribution

  • 05055331302793 ()
NCL-L-PLAP-8A9

  • Human placental alkaline phosphatase (hPLAP) IVD, antibody
NCL-SPEC1 is intended for the qualitative identification by light microscopy of Spectrin by immunohistochemistry.
LEICA BIOSYSTEMS NEWCASTLE LTD
SPEC1-CE
Not in Commercial Distribution

  • 05055331301482 ()
NCL-SPEC1

  • Spectrin IVD, antibody
NCL-L-SYNAP-299 is intended for the qualitative identification by light microscopy of Synaptophysin molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
SYNAP-299-L-CE
In Commercial Distribution

  • 05055331301352 ()
NCL-L-SYNAP-299

  • Synaptophysin IVD, antibody
NCL-L-TdT-339 is intended for the qualitative identification by light microscopy of human terminal deoxynucleotidyl transferase in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
TDT-339-L-CE
In Commercial Distribution

  • 05055331301208 ()
NCL-L-TdT-339

  • Terminal deoxynucleotidyl transferase (TdT) IVD, antibody
NCL-L-TPO is intended for the qualitative identification by light microscopy of Thyroid Peroxidase molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
TPO-L-CE
In Commercial Distribution

  • 05055331300935 ()
NCL-L-TPO

  • Thyroid peroxidase (TPO) IVD, antibody
NCL-L-TTF-1 is intended for the qualitative identification by light microscopy of Thyroid Transcription Factor-1 in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist
LEICA BIOSYSTEMS NEWCASTLE LTD
TTF-1-L-CE
In Commercial Distribution

  • 05055331300676 ()
NCL-L-TTF-1

  • Thyroid transcription factor-1 (TTF1) IVD, antibody
NCL-L-TYROS is intended for the qualitative identification by light microscopy of Tyrosinase molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
TYROS-L-CE
In Commercial Distribution

  • 05055331300584 ()
NCL-L-TYROS

  • Tyrosinase IVD, antibody
Analyte Specific Reagnet. Analytical and performance characteristics are not established.
LEICA BIOSYSTEMS NEWCASTLE LTD
VEGFR3-L-A
In Commercial Distribution

  • 05055331300430 ()
NCL-L-VEGFR3

  • Vascular endothelial growth factor (VEGF) IVD, antibody
Analyte Specific Reagent. Analytical and performance characteristics are not established.
LEICA BIOSYSTEMS NEWCASTLE LTD
VILLIN-L-A
In Commercial Distribution

  • 05055331300409 ()
NCL-L-VILLIN

  • Villin IVD, antibody
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