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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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Cytokeratin 8 (TS1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratin 8 intermediate filament. 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
PA0567
In Commercial Distribution

  • 05055331303936 ()
PA0567

  • Cytokeratin IVD, antibody
Insulin (2D11-H5) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human insulin 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
PA0620
In Commercial Distribution

  • 05055331303912 ()
PA0620

  • Insulin 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 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
PA0693
In Commercial Distribution

  • 05055331303899 ()
PA0693

  • Follicle stimulating hormone (FSH) IVD, antibody
Human Growth Hormone (Polyclonal) antibody is intended to be used for the qualitative identification by light microscopy of human growth hormone 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
PA0704
In Commercial Distribution

  • 05055331303882 ()
PA0704

  • Human growth hormone (HGH) IVD, antibody
Myoglobin (MYO18) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human myoglobin 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
PA0727
In Commercial Distribution

  • 05055331303875 ()
PA0727

  • Myoglobin IVD, antibody
Serotonin (Polyclonal) antibody is intended to be used for the qualitative identification by light microscopy of human serotonin 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
PA0736
Not in Commercial Distribution

  • 05055331303868 ()
PA0736

  • Serotonin IVD, antibody
Thyroid Stimulating Hormone (QB2/6) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of thyroid stimulating hormone 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
PA0776
Not in Commercial Distribution

  • 05055331303844 ()
PA0776

  • Thyroid stimulating hormone (TSH) IVD, antibody
CD30 (JCM182) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of CD30 protein 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
PA0790
In Commercial Distribution

  • 05055331303820 ()
PA0790

  • Tumour necrosis factor receptor superfamily IVD, antibody
Cytokeratin 19 (b170) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratin 19 intermediate filament protein 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
PA0799
In Commercial Distribution

  • 05055331303813 ()
PA0799

  • Cytokeratin IVD, antibody
CD19 (BT51E) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD19 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
PA0843
In Commercial Distribution

  • 05055331303806 ()
PA0843

  • CD19 cell marker IVD, antibody
S-100 (Polyclonal) antibody is intended to be used for the qualitative identification by light microscopy of human S-100 protein 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
PA0900
In Commercial Distribution

  • 05055331303790 ()
PA0900

  • S100 protein IVD, antibody
CD20 (MJ1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD20 antigen 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
PA0906
In Commercial Distribution

  • 05055331303783 ()
PA0906

  • CD20 cell marker IVD, antibody
Multi-Cytokeratin (AE1/AE3) antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratins 56.5, 50, 50’, 48 and 40 kD of the acidic subfamily and 65 to 67, 64, 59, 58, 56 and 52 kD of the basic subfamily 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
PA0909
In Commercial Distribution

  • 05055331303776 ()
PA0909

  • Cytokeratin IVD, antibody
Oct-3/4 (N1NK) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Oct-3/4 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
PA0934
In Commercial Distribution

  • 05055331303752 ()
PA0934

  • Oct-3/4 IVD, antibody
CD43 (MT1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD43 antigen 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
PA0938
In Commercial Distribution

  • 05055331303745 ()
PA0938

  • CD43 cell marker IVD, antibody
Cytokeratin 7 (RN7) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratin 7 intermediate filament protein 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
PA0942
In Commercial Distribution

  • 05055331303738 ()
PA0942

  • Cytokeratin IVD, antibody
Smooth Muscle Actin (alpha sm-1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human alpha smooth muscle actin 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
PA0943
In Commercial Distribution

  • 05055331303721 ()
PA0943

  • Smooth muscle actin IVD, antibody
Alpha Fetoprotein (C3) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human alpha fetoprotein 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
PA0963
In Commercial Distribution

  • 05055331303714 ()
PA0963

  • Alpha-fetoprotein (AFP) IVD, antibody
ZAP-70 (L453R) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human ZAP-70 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
PA0998
Not in Commercial Distribution

  • 05055331303691 ()
PA0998

  • Zeta chain associated protein kinase 70 (ZAP-70) IVD, antibody
Kappa Probe is intended for use in the qualitative identification of Kappa light chain messenger RNA (mRNA) in formalin-fixed, paraffinembedded tissue by in situ hybridization (ISH) using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PB0645
In Commercial Distribution

  • 05055331303554 ()
PB0645

  • Kappa/lambda light chain immunoglobulin IVD, antibody
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