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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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Human Chorionic Gonadotrophin (Polyclonal) antibody is intended to be used for the qualitative identification by light microscopy of human chorionic gonadotrophin (HCG) 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
PA0014-U
In Commercial Distribution

  • 05055331334114 ()
PA0014-U

  • Human chorionic gonadotropin beta-subunit IVD, antibody
CD117 (EP10) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD117 (c-kit) oncoprotein 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
PA0007-U
In Commercial Distribution

  • 05055331334091 ()
PA0007-U

  • CD117 (c-kit) cell marker IVD, antibody
Prostatic Acid Phosphatase (PASE/4LJ) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human prostatic acid phosphatase 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
PA0006-U
In Commercial Distribution

  • 05055331334084 ()
PA0006-U

  • Prostatic acid phosphatase (PAP) IVD, antibody
NCL-L-p63-U is intended for the qualitative identification by light microscopy of human p63 in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
P63-L-U
In Commercial Distribution

  • 05055331334077 ()
NCL-L-P63-U

  • p63 tumour protein IVD, antibody
NCL-L-p53-DO7-U is intended for the qualitative identification by light microscopy of p53 protein molecules in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
P53-DO7-L-U
In Commercial Distribution

  • 05055331334060 ()
NCL-L-P53-DO7-U

  • p53 tumour protein IVD, antibody
NCL-L-OCT3/4-U is intended for the qualitative identification by light microscopy of Oct-3/4 in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
OCT3/4-L-U
In Commercial Distribution

  • 05055331334053 ()
NCL-L-OCT3/4-U

  • Oct-3/4 IVD, antibody
NCL-L-NF200-N52-U is intended for the qualitative identification by light microscopy of NF-H (200 kD) polypeptide of human neurofilament in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
NF200-N52-L-U
In Commercial Distribution

  • 05055331334046 ()
NCL-L-NF200-N52-U

  • Neurofilament protein IVD, antibody
NCL-L-NapsinA-U is intended for the qualitative identification by light microscopy of Napsin A molecules in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
NAPSINA-L-U
In Commercial Distribution

  • 05055331334039 ()
NCL-L-NAPSINA-U

  • Napsin A IVD, antibody
NCL-L-Myf-4-U is intended for the qualitative identification by light microscopy of Myf-4 (Rhabdomyosarcoma Marker) molecules in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
MYF-4-L-U
In Commercial Distribution

  • 05055331334022 ()
NCL-L-MYF-4-U

  • Myogenin IVD, antibody
NCL-L-MUM1-U is intended for the qualitative identification by light microscopy of human multiple myeloma oncogene 1 (MUM-1) in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
MUM1-L-U
In Commercial Distribution

  • 05055331334015 ()
NCL-L-MUM1-U

  • MUM1 transcription factor IVD, antibody
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