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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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No Description
BIOCARE MEDICAL LLC
OPAI325T60
In Commercial Distribution

  • 00847627029126 ()


  • Ki67 antigen IVD, antibody
No Description
BIOCARE MEDICAL LLC
OPAI3156T60
In Commercial Distribution

  • 00847627029102 ()


  • Ki67 antigen IVD, antibody
No Description
BIOCARE MEDICAL LLC
AVI3231G25
In Commercial Distribution

  • 00847627029034 ()


  • p16 antigen IVD, antibody
No Description
BIOCARE MEDICAL LLC
API3237H
In Commercial Distribution

  • 00847627028990 ()


  • S100 protein IVD, antibody
No Description
BIOCARE MEDICAL LLC
ALI3156G7
In Commercial Distribution

  • 00847627028778 ()


  • Ki67 antigen IVD, antibody
NCL-L-CYCLIN D1-GM is intended for the qualitative identification by light microscopy of Cyclin D1 molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CYCLIND1-GM-L-CE
In Commercial Distribution

  • 05055331310897 ()
NCL-L-CYCLIND1-GM

  • Cyclin D1 IVD, antibody
NCL-L-DES-DERII is intended for the qualitative identification by light microscopy of human desmin in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
DES-DERII-L-CE
In Commercial Distribution

  • 05055331310668 ()
NCL-L-DES-DERII

  • Desmin protein IVD, antibody
NCL-L-GRAN-B is intended for the qualitative identification by light microscopy of Granzyme B molecules 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
GRAN-B-L-CE
In Commercial Distribution

  • 05055331308689 ()
NCL-L-GRAN-B

  • Granzyme B IVD, antibody
NCL-L-Ki67-MM1 is intended for the qualitative identification by light microscopy of Ki67 Antigen molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
KI67-MM1-L-CE
In Commercial Distribution

  • 05055331307507 ()
NCL-L-Ki67-MM1

  • Ki67 antigen IVD, antibody
NCL-L-MLH1 is intended for the qualitative identification by light microscopy of Mismatch Repair Protein (MLH1) molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
MLH1-L-CE
In Commercial Distribution

  • 05055331306296 ()
NCL-L-MLH1

  • MLH1 antigen IVD, antibody
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