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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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Lambda Light Chain (SHL53) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human lambda light chains in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0570
In Commercial Distribution

  • 05055331319128 ()
PA0570

  • Kappa/lambda light chain immunoglobulin IVD, antibody
Kappa Light Chain (CH15) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human kappa light chains in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0606
In Commercial Distribution

  • 05055331319111 ()
PA0606

  • Kappa/lambda light chain immunoglobulin IVD, antibody
Melanoma Marker (HMB45) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human HMB45 antigen in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0027
In Commercial Distribution

  • 05055331319104 ()
PA0027

  • Melanoma specific protein IVD, antibody
NCL-L-MSA-594 is intended for the qualitative identification by light microscopy of muscle specific actin molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
MSA-594-L-CE
In Commercial Distribution

  • 05055331318572 ()
NCL-L-MSA-594

  • Muscle-specific alpha/gamma actin IVD, antibody
NCL-L-Hpylori is intended for the qualitative identification by light microscopy of Helicobacter pylori in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
HPYLORI-L-CE
In Commercial Distribution

  • 05055331318541 ()
NCL-L-Hpylori

  • Helicobacter pylori antigen IVD, antibody
NCL-L-PMS2 is intended for the qualitative identification by light microscopy of PMS2 molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
PMS2-L-CE
In Commercial Distribution

  • 05055331318480 ()
NCL-L-PMS2

  • Postmeiotic segregation increased 2 (PMS2) IVD, antibody
NCL-L-CD123 is intended for the qualitative identification by light microscopy of CD123 molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD123-L-CE
In Commercial Distribution

  • 05055331318466 ()
NCL-L-CD123

  • Interleukin-3 receptor (IL-3r) IVD, antibody
NCL-L-CALCITONIN is intended for the qualitative identification by light microscopy of calcitonin molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CALCITONIN-L-CE
In Commercial Distribution

  • 05055331318411 ()
NCL-L-CALCITONIN

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

  • 05055331318350 ()
NCL-L-InhibinA

  • Inhibin A IVD, antibody
NCL-L-CD99-187 is intended for the qualitative identification by light microscopy of CD99 molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD99-187-L-CE
In Commercial Distribution

  • 05055331318312 ()
NCL-L-CD99-187

  • CD99 cell marker IVD, antibody
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