For in vitro diagnostic use.ChromoPlex 1 Dual Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker and polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the visualization of tissue-bound mouse IgG and rabbit primary antibodies. It is intended for target visualization by immunohistochemistry (IHC) in sections of formalin fixed, paraffin-embedded tissue using the automated BOND-PRIME system.The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist.ChromoPlex 1 Dual Detection for BOND-PRIME is intended to be used with other devices for visualization of staining and as such, qualitative or semi-quantitative diagnostic function including specific disease indication and intended use population is described within the associated device labelling as required for that device.

NCL-L-PAX-5-U is intended for the qualitative identification by light microscopy of human Pax-5 in paraffin sections.

NCL-L-PGP9.5-U is intended for the qualitative identification by light microscopy of Protein Gene Product 9.5 molecules in parrafin sections.

NCL-L-PLAP-8A9-U is intended for the qualitative identification by light microscopy of Placental Alkaline Phosphatase molecules in parrafin sections.

NCL-L-PMS2-U is intended for the qualitative identification by light microscopy of PMS2 molecules in parrafin sections.

NCL-L-PSA-431-U is intended for the qualitative identification by light microscopy of human prostate specific antigen in parrafin sections.

NCL-L-PTH-488-U is intended for the qualitative identification by light microscopy of human parathyroid hormone in parrafin sections.

NCL-L-S100-167-U is intended for the qualitative identification by light microscopy of S-100B protein in parrafin sections.

NCL-L-SMA-U is intended for the qualitative identification by light microscopy of human alpha smooth muscle actin in parrafin sections.

NCL-L-SYNAP-299 is intended for the qualitative identification by light microscopy of Synaptophysin molecules in paraffin sections.

NCL-L-SYNAP-299-U is intended for the qualitative identification by light microscopy of Synaptophysin molecules in parrafin sections.

NCL-L-TdT-339 is intended for the qualitative identification by light microscopy of human terminal deoxynucleotidyl transferase in paraffin sections.

NCL-L-TdT-339-U is intended for the qualitative identification by light microscopy of human terminal deoxynucleotidyl transferase in parrafin sections.

NCL-L-TPO is intended for the qualitative identification by light microscopy of Thyroid Peroxidase molecules in paraffin sections.

NCL-L-TPO-U is intended for the qualitative identification by light microscopy of Thyroid Peroxidase molecules in parrafin sections.

NCL-L-TTF-1 is intended for the qualitative identification by light microscopy of Thyroid Transcription Factor-1 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

NCL-L-TTF-1-U is intended for the qualitative identification by light microscopy of Thyroid Transcription Factor-1 in parrafin sections.

NCL-L-TYROS is intended for the qualitative identification by light microscopy of Tyrosinase molecules in paraffin sections.

NCL-L-TYROS-U is intended for the qualitative identification by light microscopy of Tyrosinase molecules in parrafin sections.

Analyte Specific Reagnet. Analytical and performance characteristics are not established.

Analyte Specific Reagent. Analytical and performance characteristics are not established.

NCL-L-VIM-572 is intended for the qualitative identification by light microscopy of Vimentin molecules in paraffin sections.

NCL-L-VIM-V9 is intended for the qualitative identification by light microscopy of human vimentin intermediate filament protein in paraffin sections.

NCL-L-VIM-V9-U is intended for the qualitative identification by light microscopy of human vimentin intermediate filament protein in parrafin sections.

NCL-L-WT1-562 is intended for the qualitative identification by light microscopy of human Wilms’ Tumor WT1 gene product in paraffinsections.

NCL-L-WT1-562-U is intended for the qualitative identification by light microscopy of human Wilms’ Tumor WT1 gene product in parrafin sections.

NCL-L-ZAP-70 is intended for the qualitative identification by light microscopy of ZAP-70 molecules in paraffin sections.

NCL-SPEC1 is intended for the qualitative identification by light microscopy of Spectrin by immunohistochemistry.

This reagent is for in vitro diagnostic use. SOX10 (SOX10/991) is intended to be used for the qualitative identification by light microscopy of human SOX10 protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX, BOND-III or BOND-PRIME systems. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist.

This reagent is for in vitro diagnostic use. Arginase-1 (EPR6672(B)) is intended to be used for the qualitative identification by light microscopy of human Arginase-1 protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX or BOND-III systems. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist.

This reagent is for in vitro diagnostic use. EpCAM (EPR20532-222) is intended to be used for the qualitative identification by light microscopy of human EpCAM in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX, BOND-III or BOND-PRIME systems. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist.

This reagent is for in vitro diagnostic use. Desmoglein 3 (EPR14101) is intended to be used for the qualitative identification by light microscopy of human Desmoglein 3 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX, BOND-III or BOND-PRIME systems. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist.

This reagent is for in vitro diagnostic use. H-Caldesmon (BSB-19) is intended to be used for the qualitative identification by light microscopy of human H-Caldesmon protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX, BOND-III or BOND-PRIME systems. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist.

This reagent is for in vitro diagnostic use. LEF-1 (EPR2029Y) is intended to be used for the qualitative identification by light microscopy of human LEF-1 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX, BOND-III or BOND-PRIME systems. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist.

CD30 (JCM182) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD30 protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).

Anaplastic Lymphoma Kinase (5A4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of ALK and ALK fusion proteins in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).

Programmed Death Ligand 1 (73-10) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of PD-L1 protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).

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).

Carcinoembryonic Antigen (CD66e) (COL-1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human carcinoembryonic antigen (CEA) in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).

This reagent is for in vitro diagnostic use. GLUT1 (GLUT1/2475) is intended to be used for the qualitative identification by light microscopy of human GLUT1 in formalin-fixed, paraffin embedded tissue by immunohistochemical staining using the automated BOND-MAX, BOND-III or BOND-PRIME systems. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist.

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).

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 BOND-MAX, BOND-III, and BOND-PRIME systems).

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 BOND-MAX, BOND-III, and BOND-PRIME systems).

This reagent is for in vitro diagnostic use. IgG4 (HP6023) is intended to be used for the qualitative identification by light microscopy of human IgG4 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX, BOND-III or BOND-PRIME systems. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist.

Novolink™ Polymer Detection Systems are used for the visualization of mouse IgG, mouse IgM and rabbit IgG primary antibodies. Novolink™ Polymer and Novolink™ DAB (Polymer) contain component reagents of these systems and are intended for use in the procedure described below.

Novolink Polymer Detection Systems are used for the visualization of mouse IgG, mouse IgM and rabbit IgG primary antibodies. Novolink™ Polymer and Novolink™ DAB (Polymer) contain component reagents of these systems and are intended for use in the procedure described below.

Novolink™ Polymer Detection Systems are used for the visualization of mouse IgG, mouse IgM and rabbit IgG primary antibodies. Novolink™ Polymer and Novolink™ DAB (Polymer) contain component reagents of these systems and are intended for use in the procedure described below.

Novolink™ Polymer Detection Systems are used for the visualization of mouse IgG, mouse IgM and rabbit IgG primary antibodies. Novolink™ Polymer and Novolink™ DAB (Polymer) contain component reagents of these systems and are intended for use in the procedure described below.

Bond Oracle HER2 IHC System is a semi quantitative immunohistochemical assay to determine HER2 oncoprotein status in breast cancer in breast tissue processed for histological evaluation.