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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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Marking Caliper
DUCKWORTH AND KENT LIMITED
9-649
In Commercial Distribution

  • 05055313814283 ()
9-649

  • Ophthalmic calliper
CD43 (MT1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD43 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
PA0938-U
In Commercial Distribution

  • 05055331335517 ()
PA0938-U

  • CD43 cell marker IVD, antibody
Multi-Cytokeratin (AE1/AE3) antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratins 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
PA0909-U
In Commercial Distribution

  • 05055331335500 ()
PA0909-U

  • Cytokeratin IVD, antibody
Immunoglobulin G (RWP49) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human immunoglobulin G (IgG) 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
PA0905-U
In Commercial Distribution

  • 05055331335494 ()
PA0905-U

  • Total immunoglobulin G (IgG total) IVD, antibody
CD19 (BT51E) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD19 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
PA0843-U
In Commercial Distribution

  • 05055331335470 ()
PA0843-U

  • CD19 cell marker IVD, antibody
Gross Cystic Disease Fluid Protein-15 (23A3) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of (15 kD) human gross cystic disease fluid protein (GCDFP15) 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
PA0708-U
In Commercial Distribution

  • 05055331335388 ()
PA0708-U

  • Gross cystic disease fluid protein-15 IVD, antibody
Human Growth Hormone (Polyclonal) antibody is intended to be used for the qualitative identification by light microscopy of human growth hormone (HGH) 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
PA0704-U
In Commercial Distribution

  • 05055331335371 ()
PA0704-U

  • Human growth hormone (HGH) IVD, antibody
Human Follicle Stimulating Hormone (INN-hFSH-60) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human follicle stimulating hormone (FSH) 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
PA0693-U
In Commercial Distribution

  • 05055331335364 ()
PA0693-U

  • Follicle stimulating hormone (FSH) 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 the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0625-U
In Commercial Distribution

  • 05055331335333 ()
PA0625-U

  • Melanoma specific protein IVD, antibody
CD79a (JCB117) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD79a 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
PA0599-U
In Commercial Distribution

  • 05055331335302 ()
PA0599-U

  • CD79a cell marker IVD, antibody
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