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

Progesterone Receptor (PGR) Clone 16 monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining.

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

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

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).

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).

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).

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).

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).

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).

Thyroid Stimulating Hormone (QB2/6) monoclonal antibody is intended to be used for the qualitative identification by light microscopy ofthyroid stimulating hormone in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BONDsystem (includes Leica BOND-MAX system and Leica BOND-III system).

Negative (Rabbit) is intended to be used as a rabbit negative control for qualitative immunohistochemical staining using an automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).

Negative (Mouse) is intended to be used as a mouse negative control for qualitative immunohistochemical staining using an automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).

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).

EBER Probe is intended for use in the qualitative identification of latent EBV infection1-2 in formalin-fixed, paraffin-embedded tissue by in situ hybridization (ISH) using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).

CMV Probe is intended to be used for the qualitative identification of human cytomegalovirus early gene RNA transcript, in formalin-fixed, paraffin-embedded tissue by in situ hybridization (ISH) using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).

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).

Lambda Probe is intended for use in the qualitative identification of Lambda light chain messenger RNA (mRNA) in formalin-fixed, paraffin-embedded tissue by in situ hybridization (ISH) using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).

The DNA Positive Control Probe is intended for use as a positive control in formalin-fixed, paraffin-embedded tissue by DNA in situ hybridization (ISH) using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).

DNA Negative Control is intended for use in the identification of background staining resulting from non-specific interactions in formalinfixed,paraffin-embedded tissue by in situ hybridization (ISH) using the automated BOND system (includes Leica BOND-MAX systemand Leica BOND-III system).

HPV Probe (Subtypes 6,11) is intended to be used for the qualitative identification of the Human Papillomavirus (HPV) DNA in formalinfixed, paraffin-embedded tissue by in situ hybridization (ISH) using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system). This probe binds to the low risk HPV subtypes 6 and 11.

RNA Positive Control Probe is intended for use as a positive control in formalin-fixed, paraffin-embedded tissue by in situ hybridization (ISH) using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).

RNA Negative Control Probe is intended for use in the identification of background staining resulting from non-specific interactions informalin-fixed, paraffin-embedded tissue by in situ hybridization (ISH) using the automated BOND system (includes Leica BOND-MAXsystem and Leica BOND-III system).

HPV Probe (Subtypes 16, 18, 31, 33, 51) is intended to be used for the qualitative identification of the Human Papillomavirus (HPV) DNAin formalin-fixed, paraffin-embedded tissue by in situ hybridization (ISH) using the automated BOND system (includes Leica BOND-MAXsystem and Leica BOND-III system). This probe binds to the five high risk HPV subtypes, 16, 18, 31, 33 and 51.

The NovocastraTM Peroxidase Block RE7101 is intended for use in the peroxidase based immunohistochemical (IHC) staining procedures described in the Instructions for Use of the NovocastraTM Peroxidase Detection Systems RE7110-K/RE7120-K, NovocastraTM Concentrated Peroxidase Detection System RE7130-K and NovoLinkTM Polymer Detection Systems RE7140-K/RE7150-K.

The Novocastra™ Protein Block RE7102 is intended for use in immunohistochemical (IHC) staining procedure described in the Instructions for Use of the NovocastraTM Peroxidase Detection Systems RE7110-K/RE7120-K, NovocastraTM Concentrated Peroxidase Detection System RE7130-K and NovoLinkTM Polymer Detection Systems RE7140-K/RE7150-K.

Novocastra™ Peroxidase Detection Systems (250 tests) RE7110-K and (500 tests) RE7120-K are for the visualization of mouse IgG,mouse IgM and rabbit IgG primary antibodies. Novocastra™ DAB (250 Slides) RE7190-K, Novocastra™ Biotinylated Secondary AntibodyRE7103 and Novocastra™ Streptavidin-HRP RE7104 are component reagents of these systems that are intended for use in theprocedure described below.

Novocastra™ Hematoxylin RE7107 is intended for use in immunohistochemical (IHC) staining procedures such as those described in the Instructions for Use of the Novocastra™ Peroxidase Detection Systems RE7110-K/RE7120-K, Novocastra™ Concentrated Peroxidase Detection System RE7130-K and Novolink™ Polymer Detection Systems RE7140-K/RE7150-K.

Novocastra™ Peroxidase Detection Systems (250 tests) RE7110-K and (500 tests) RE7120-K are for the visualization of mouse IgG,mouse IgM and rabbit IgG primary antibodies. Novocastra™ DAB (250 Slides) RE7190-K, Novocastra™ Biotinylated Secondary AntibodyRE7103 and Novocastra™ Streptavidin-HRP RE7104 are component reagents of these systems that are intended for use in theprocedure described below.

The Novocastra™ Epitope Retrieval Solutions RE7113, RE7114, RE7116 and RE7119 are intended for Heat Induced Epitope Retrieval on formalin-fixed, paraffin-embedded tissue sections as part of an immunohistochemical procedure.

The Novocastra™ Epitope Retrieval Solutions RE7113, RE7114, RE7116 and RE7119 are intended for Heat Induced Epitope Retrieval on formalin-fixed, paraffin-embedded tissue sections as part of an immunohistochemical procedure.

The Novocastra™ Epitope Retrieval Solutions RE7113, RE7114, RE7116 and RE7119 are intended for Heat Induced Epitope Retrieval on formalin-fixed, paraffin-embedded tissue sections as part of an immunohistochemical procedure.

Novocastra™ Peroxidase Detection Systems (250 tests) RE7110-K and (500 tests) RE7120-K are for the visualization of mouse IgG,mouse IgM and rabbit IgG primary antibodies. Novocastra™ DAB (250 Slides) RE7190-K, Novocastra™ Biotinylated Secondary AntibodyRE7103 and Novocastra™ Streptavidin-HRP RE7104 are component reagents of these systems that are intended for use in theprocedure described below.

Novocastra™ IHC Diluent RE7133 is intended for use as a diluent for Novocastra™ primary antibodies, Novocastra™ ConcentratedBiotinylated Secondary Antibody RE7108 and Novocastra™ Concentrated Streptavidin-HRP RE7109 in immunohistochemical (IHC) procedures.

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.

NovocastraTM Enzyme Proteinase K (IHC) is intended for the enzymatic pretreatment of formalin-fixed, paraffin-embedded tissue sections prior to incubation with a primary antibody in an immunohistochemical (IHC) procedure.

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.