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Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636 is intended for use in the qualititative detection of human progesterone receptor in tissue sections of human breast cancer by immunohistochemistry. The assay is intended for use as an aid in selecting patients most likely to benefit from hormonal therapy as well as an aid in the prognosis and management of breast cancer.

1) Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, (Product Code No. M3569) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant. The antibody is supplied in 0.05M Tris-HCl buffer, pH 7.2, containing fetal bovine serum and 15mM sodium azide. (0.2 mL and 1 mL total volume). 2) Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use Antibody (Product Code No. N1630) consists of a mouse anti-human monoclonal antibody produced as a tissue culture supernatant and pre-diluted in 0.05M Tris-HCl buffer, pH 7.6, containing fetal bovine serum and 15mM sodium azide (7mL and 11 mL sizes). 3) Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use Antibody (Product Code No. NP008) consists of a mouse anti-human monoclonal antibody produced as a tissue culture supernatant and pre-diluted in 0.05M Tris-HCl buffer, pH 7.6, containing fetal bovine serum and 15mM sodium azide (7mL total volume).

Monoclonal Mouse Anti-Human Estrogen Receptor, Clone 1D5 may be used in the semi-quantitative detection of human estrogen receptor in tissue sections of human breast cancer by immunohistochemistry. The information gained by this assay can aid in assessing the likelihood of response to therapy as well as in the prognosis and management of breast cancer patients. The clinical interpretation of any positive staining or its absence should be complemented by morphological and histological studies with proper controls. Evaluations should be made within the context of the patient's clinical history and other diagnostic tests by a qualified individual having knowledge of all the potential antibody reactivities.

1) Monoclonal Mouse Anti-Human Estrogen Receptor, Clone 1D5, Device Code No. M7047) is a mouse anti-human monoclonal antibody (Product) produced as a tissue culture supernatant. The antibody is supplied in Description: 0.05M Tris-HCl buffer, pH 7.2, containing fotal bovine serum and 15mM sodium azide. (1mL total volume). 2) Monoclonal Mouse Anti-Human Estrogen Receptor. Clone 105 Ready-to-Use Antibody and Negative Control (Product Code No. N1576) consists of a mouse anti-human monoclonal antibody produced as a tissue culture supernatant and pre-diluted in 0.05M Tris-HCI buffer, pH 7.6, containing fotal bovine serum and 15mM sodium azide (7mL total volume). The primary antibody is packaged with a negative control reagent consisting of a cocktail of purified mouse immunoglobulins (IgG, IgG, IgGz, IgGz, IgGz and IgM) in 0.05M Tris-HCI buffer, pH 7.6 and 15mM sodium azide (5mL total volume).

For In Vitro Diagnostic Use Monoclonal Mouse Anti-Human T-cell, CD3/RPE-Cy5 conjugated, Clone UCHT1 (Code No.C7067) (Anti-CD3/RPE-Cy5) and Monoclonal Mouse Anti-Human T-cell, CD3/RPE conjugated, Clone UCHT1 (Code No. R0810) (Anti-CD3/RPE) have been developed for use in flow cytometry for the analysis of T-cells in peripheral blood. These reagents allow simultaneous detection and quantification of CD3-positive cells (T-cells) in normal and pathological conditions such as immunodeficiency disorders. Each reagent is one component of the suggested monoclonal antibody (MAb) combinations for routine immunophenotyping of lymphocytes in peripheral blood. Immunophenotyping of lymphocytes is widely applied for diagnosis of immunodeficiencies. DAKO Anti-CD3/RPE-Cy5 is one of the reagents utilized when performing immunophenotyping of lymphocytes. Monoclonal Mouse Anti-Human T-cell, CD3, Clone UCHT1, RPE conjugated, has been developed for use in flow cytometry for the analysis of T-cells. This reagent allows simultaneous detection and quantification of CD3-positive cells (T-cells) in normal and pathological conditions such as immunodeficiency disorders. It is one component of the suggested monoclonal antibody (MAb) combinations for routine immunophenotyping of lymphocytes in peripheral blood. Immunophenotyping of lymphocytes is widely applied for diagnosis of immunodeficiencies. DAKO Anti-CD3/RPE is one of the reagents utilized when performing immunophenotyping of lymphocytes.

Monoclonal Mouse Anti-Human T-cell, CD3/RPE-Cy5 conjugated, Clone UCHT1 (Code No. C7067) and Monoclonal Mouse Anti-Human T-cell, CD3/RPE conjugated, Clone UCHT1 (Code No. R0810) are specific for T-lymphocyte cluster determinants as evaluated by the International Workshop on Human Leukocyte Differentiation Antigens. UCHT1 CD3-specific monoclonal antibody was designated B28 antibody at the Second Workshop (Reinherz, EL, Haynes, BF, Nadler, LM, Bernstein, ID, eds. Leukocyte Typing II, Vol. 2. New York-Berlin-Heidelberg-Tokyo: Springer Verlag, 1986.) Purified monoclonal mouse anti-human CD3 is produced in tissue culture, dialyzed and conjugated with either R-phycoerythrin (RPE) covalently coupled to cyanin 5 (Cy5) or R-phycoerythrin (RPE). One ml (1.0 ml) containing the conjugated antibody is supplied in 0.05M Tris-HCl buffer, pH 7.2, 15mM NaN3, 0.1M NaCl, stabilized with 1% stabilzing protein. Monoclonal Mouse Anti-Human T-cell, CD3/RPE-Cy5-conjugated, C7067, and, Monoclonal Mouse Anti-Human T-cell, CD3/RPE, R0810 are specific for T-lymphocyte cluster determinants as evaluated by the International Workshop on Human Leukocyte Differentiation Antigens. UCHT1 CD3-specific monoclonal antibody was designated B28 antibody at the Second Workshop (Reinherz, EL, Haynes, BF, Nadler, LM, Bernstein, ID, eds. Leukocyte Typing II, Vol. 2. New York-Berlin-Heidelberg-Tokyo: Springer Verlag, 1986.) Purified monoclonal mouse anti-human CD3 is produced in tissue culture, dialyzed and conjugated with R-phycoerythrin (RPE) covalently coupled to cyanin 5 (Cy5), or conjugated with R-phycoerythrin (RPE). One ml (1.0 ml) containing the conjugated antibody is supplied in 0.05M Tris-HCl buffer, pH 7.2, 15mM NaNg, 0.1M NaCl, stabilized with 1% carrier protein.

Mouse IgG1, clone DAK-GO1 Negative Control Reagents are fluorescent conjugated (fluorescein isothiocyanate isomer 1 (FITC), R-Phycoerythrin (RPE), or R-Phycoerythrin-Cyanin 5 (RPE-CY5)) monoclonal antibodies that have been developed for use as negative control reagents for FITC, RPE or RPE-CY5 conjugated monoclonal antibodies of the IgG, heavy chain isotype in preparations of normal whole peripheral blood by flow cytometric methods. Negative control reagents are one component of the suggested controls for monoclonal antibody (MAb) combinations for routine immunophenotyping of lymphocytes in peripheral blood.

Monoclonal Mouse IgG₁, DAK-GO1 FITC, RPE or RPE-CY5 conjugated are directed against Aspergillus niger glucose oxidase, an enzyme that is neither present nor inducible in mammalian tissues. Purified monoclonal mouse IgG1 is produced in tissue culture, dialyzed and conjugated with Fluorescein (FITC), R-phycoerythrin (RPE), or R-phycoerythrin (RPE) covalently coupled to cyanin 5 (Cy5). FITC CONJUGATED: One ml (1.0 ml) containing the conjugated antibody is supplied in 0.05M Tris-HCl buffer, pH 7.2, 15mM NaN₃, stabilized with 1% carrier protein. RPE and RPE-Cy5 CONJUGATED: One ml (1.0 ml) containing the conjugated antibody is supplied in 0.05M Tris-HCI buffer, pH 7.2, 15mM NaN₃, 0.1M NaCl stabilized with 1% carrier protein

Monoclonal Mouse Anti-Human B-cell, CD19, Clone HD37, RPE-Cy5 conjugated, has been developed for use in flow cytometry for the analysis of B-cells. This reagent allows simultaneous detection and quantification of CD19-positive cells (B-cells) in normal and pathological conditions such as immunodeficiency disorders. It is one component of the suggested monoclonal antibody (MAb) combinations for routine immunophenotyping of lymphocytes in peripheral blood. Immunophenotyping of lymphocytes is widely applied for detection and classification of hematovojetic malignancies, and for diagnosis of immunodeficiencies. DAKO Anti-CD19/Cy5 is one of the reagents utilized when performing immunophenotyping of lymphocytes.

Monoclonal Mouse Anti-Human B-cell, CD19, RPE-Cy5-conjugated, Clone HD37 is specific for B-lymphocyte cluster determinants as evaluated by the International Workshop on Human Leukocyte Differentiation Antigens. HD37 CD19-specific monoclonal antibody was designated B28 antibody at the Second Workshop (Reinherz, EL, Haynes, BF, Nadler, LM, Bernstein, ID, Leukocyte Typing II, Vol. 2. New York-Berlin-Heidelberg-Tokyo: eds. Springer Verlag, 1986.) Purified monoclonal mouse anti-human CD19 is produced in tissue culture, dialyzed and conjugated with R-phycoerythrin (RPE) covalently coupled to cyanin 5 (Cy5). One ml (1,0 ml) containing the conjugated antibody is supplied in 0.05M Tris-HCI buffer, pH 7.2, 15mM NaN3, 0.1M NaCl, stabilized with 1% carrier protein.

Monoclonal Mouse Anti-Human Cytokeratin, High Molecular Weight, clone 34βE12 (34βE12) is intended for laboratory use to qualitatively identify by light microscopy the 66, 57, 51 and 49kD3 proteins corresponding to cytokeratins 1, 5, 10 and 14 of the Moll catalog in acetone or methanol fixed, frozen and formalin, methacarn or Carnoy's fixed, paraffin embedded tissues. 34BE12 specifically binds to antigens located in the cytoplasm of normal squamous and ductal epithelial cells. Positive results aid in the classification of normal and abnormal cells and tissues and serve as an adjunct to conventional histopathology. The clinical interpretation of any positive staining or its absence should be complemented by morphological and histological studies with proper controls. Evaluations should be made within the context of the patient's clinical history and other diagnostic tests by a qualified individual. Anti-Human Cytokeratin. High Molecular Weight, Clone 34BE12 Antibody may be used as one member of a panel of antibodies to aid in the differential diagnosis of anaplastic cells of undetermined origin. When used with markers of simple epithelium, it can aid in the differentiation of carcinomas from non epithelial tumors, e.g., gliomas, lymphomas, melanomas, sarcomas or seminomas. Because it does not react with all carcinomas, it may be used also as an aid in the subclassification of carcinomas. It is also useful in the differential diagnosis of small-acinar lesions of the prostate gland because it stains basal cells which are absent in the disease.

1) Monoclonal Mouse Anti-Human Cytokeratin, High Molecular Weight, clone 34βE12 (Product Code No. M0630) is a mouse anti-human antibody produced as a tissue culture supernatant. The antibody is supplied in 0.05M Tris-HCl buffer, pH 7.2, containing fetal calf serum and 15mM sodium azide. (1mL total volume). 2) Ready-to-Use Monoclonal Mouse Anti-Human Cytokeratin, High Molecular Weight, clone 34βE12 Antibody and Negative Control (Product Code No. N1553) consists of a mouse anti-human monoclonal antibody produced as a tissue culture supernatant and pre-diluted in 0.05M Tris-HCl buffer, pH 7.6, containing fetal calf serum and 15mM sodium azide (7mL total volume). The primary antibody is packaged with a negative control reagent consisting of fetal calf serum in 0.05M Tris-HCl buffer, pH 7.6 and 15mM sodium azide (5mL total volume).

Monoclonal mouse anti-human Ki-1 antigen, CD30, Clone Ber-H2 (Ber-H2), may be used as one member of a panel of antibodies to aid in the differential diagnosis of large anaplastic cells of undetermined origin. This antibody stains cell membranes of most cases of anaplastic large cell lymphomas (ALCL), often called Ki-1 lymphomas. It also stains cell membranes and/or cyoplasm of most Hodgkin's lymphomas. Ber-H2 is a valuable aid in the assessment of cutaneous lymphoid infiltrates, particularly when large atypical cells are present. Most nonhomatolymphoid neoplasms are negative with Ber-H2, although there are several significant exceptions. Membrane positivity is seen with embryonal carcinomas, and weak, diffuse cytoplasmic positivity is seen in pancreatic and salivary gland carcinomas. The staining pattern is most often described as strong membranous and weaker cytoplasmic, specifically paranuclear dot-positivity of the Golgi region. The weak, diffuse cytoplasmic staining is considered to be unexpected, non-specific labeling. It may be reduced or removed by changing the protease pretreatment of the paraffin sections and/or further dilution of the Ber-H2 antibody.

1) Monoclonal Mouse Anti-Human Ki-1 antigen, CD30, Clone Ber-H2 (Product Code No. M0751) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant. The antibody is supplied in 0.05M Tris-HCl buffer, pH 7.2, containing 0.015M sodium azide. (1 ml total volume) 2) Ready To Use Monoclonal Mouse Anti-Human Ki-1 antigen, CD30, Clone Ber-H2 Primary Antibody and Negative Control Reagent (Product Code No. N1558) consists of a mouse anti-human monoclonal antibody produced as a tissue culture supernatant and pre-diluted in 0.05M Tris-HCl buffer, pH 7.6, containing carrier protein and 0.015M sodium azide (7mL total volume). The primary antibody is packaged with a negative control reagent consisting of fetal calf serum in 0.05M Tris-HCl buffer, pH 7.6, containing carrier protein and 0.015M sodium azide (5 ml total volume). The primary antibody and the negative control reagent contain equivalent total protein concentrations.

Monoclonal Mouse Anti-Human Leukocyte Common Antigen, CD45, FITC-Conjugated, Clone T29/33 Monocrollar Wouse First House Anti-Human Mouse Anti-Human Monocyte. CD14, RPE-Conjugated, Clone TUK4 (Anti-CD) 1/RPE, TÜK4) have been developed for use in flow cytometry. This reagent may be used to optimize the gating of lymphocytes when analyzing peripheral whole blood or peripheral blood mononuclear cell preparations. This reagent is one component of the suggested monoclonal antibody (MAb) combination for routine immunophenoryping of lymphocytes in peripheral blood.

Purified mouse anti-human CD45, Clone T29/33, conjugated with fluorescein isothiocyanate, isomer 1 (FITC) + purified mouse anti-human CD14, Clone TUK4, conjugated with R-phycoerythrin, present in 0.05M Tris-HCl buffer, pH 7.2, 15 mM NaN3, 0.1M NaCl, stabilized with 1% carrier protein Subpopulations of lymphocytes may be stained with fluorochrome-conjugated antibody and evaluated in peripheral blood specimens when contaminating red blood cells (RBC's) are lysed prior to flow cytometric analysis. A subpopulation of WBC's are selected for assessment based upon cell morphology.

For In Vitro Diagnostic Use Mouse Anti-Human T-cell, CD3/FITC, UCHT1 + - Mouse Anti-Human T-cell, CD4/RPE, MT310 (DAKO Anti-CD3/FITC and Anti-CD4/RPE) has been developed for use in flow cytometry for the analysis of CD3 and CD4* T-cells. This reagent allows simultaneous detection and quantification of CD3*CD4* cells (CD4 positive T-lymphocytes) in normal and pathological conditions such as immunodeficiency disorders. It is one component of the suggested monoclonal antibody (MAb) combinations for routine immunophenotyping of lymphocytes in peripheral blood using flow cytometry.

Purified mouse anti-human CD3, Clone UCHT1, conjugated with fluorescein isothiocyanate, isomer 1 (FITC) + purified mouse anti-human CD4, Clone MT310, conjugated with R-phycoerythrin, present in 0.05M Tris-HCl buffer, pH 7.2, 15 mM NaNo, 0.1M NaCl, stabilized with 1% carrier protein Subpopulations of lymphocytes may be stained with fluorochrome-conjugated antibody and evaluated in peripheral blood specimens when contaminating red blood cells (RBC's) are lysed prior to flow cytometric analysis. A subpopulation of WBC's are selected for assessment based upon cell morphology.

Immunoenzymatic/immunohistochemical (IHC) staining techniques allow for the qualitative identification of tissue antigens. Antigens are visualized via the sequential application of a specific antibody to the antigen (primary antibody) and a detection system. Immunohistochemical detection systems usually consist of a secondary antibody to the primary antibody (link antibody), an enzyme complex and a chromogenic substrate. The enzymatic activation of the chromogen yields a visible reaction product at the antigen site. Results aid in the diagnosis of pathophysiological processes which may or may not be associated with a particular antigen.

The DAKO LSAB® 2 Kit, HRP (Code No. K0677) is based on a modified labeled avidin-biotin (LAB) technique in which a biotinylated secondary antibody forms a complex with peroxidase-conjugated streptavidin molecules. This kit is very similar to the original DAKO LSAB® Kit, HRP (K0680) previously cleared in submission K924726. Refinements to the LSAB® 2 Kit include the elimination of a separate protein blocking reagent incubation and reconfigured substrate-chromogen reagents. The DAKO Envision™ Systems, HRP, contains a Peroxidase Blocking Reagent similar to the Hydrogen Peroxide provided with the LSAB® and LSAB® 2 Kit, the Envision™ System does not require a protein blocking reagent incubation. The Envision™ System also eliminates the sequential applications of link antibody and streptavidin common to the LSAB® 2 Kits. A polymer, labeled with goat anti-mouse and goat anti-rabbit immunoglobulins conjugated to horseradish peroxidase eliminates these steps. The DAKO Envision™ System offers the user a choice of two protocols. Protocol #1 consecutively incubates the primary antibody and Peroxidase Labeled Polymer for ten (10) minutes. Protocol #2 increases the staining intensity of the Envision™ System by lengthening the incubations of the primary antibody and the labeled polymer to thirty (30) minutes. The DAKO Envision™ System. HRP, is available with DAB (Code No. K1390) or Ready-to-Use AEC substrate-chromogen (Code No. K1391). Both systems use the same Peroxidase Blocking Reagent and Peroxidase Labeled Polymer. Concentrated primary rabbit/mouse antibodies or DAKO® Ready-to-Use N-Series Primary Antibodies and Negative Control Reagents are suitable for use with the DAKO LSAB® 2 Kit and DAKQ Envision™ Systems. Primary antibodies are not included with the DAKO LSAB® 2 Kit, HRP or DAKO Envision™ Systems, and must be purchased separately by the user.