Profile: Dako North America, Inc. focuses on tissue-based cancer diagnostics like immunohistochemistry, in situ hybridization, flow cytometry, bulk antibodies for turbidometry and ELISA kits. We provide reagents, instruments and software for cancer diagnosis & laboratory processes. Our automated cellular imaging system (ACIS® III) offers IVD applications for HER2, ER and PR. When used in conjunction with HercepTest™, its image analysis application may assist pathologists in determining the status of HER2 protein expression, to aid in the assessment of breast cancer patients eligible for Herceptin® therapy. It can also integrate into Dako Link allowing for electronic transfer of information required for sample processing across different systems. The Dako link cassette printer is a complete automated printing system designed to provide permanent, indelible markings on tissue cassettes for specimen handling. The laser imager produces text and high-resolution linear & two-dimensional barcode markings directly on to the surface of specially coated cassettes. The printer is designed to be part of the Dako link workflow solution.

The company has revenues of USD 25-50 Million, has ~180 employees and is ISO 9001 certified.

FDA Registration Number: 2022180

51 to 100 of 158 Products/Services (Click for related suppliers)  Page: 1 [2] 3 4

• Denaturation Instruments

• Differential Cell Counter (FDA Code: GKZ / 864.5220) An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.

• Dye Solution Stain (FDA Code: LEE / 864.1850) Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

• Electrophoresis Instrumentation (FDA Code: JZS / 866.4500) Immunoelectrophoresis equipment for clinical use with its electrical power supply is a device used for separating protein molecules. Immunoelectrophoresis is a procedure in which a complex protein mixture is placed in an agar gel and the various proteins are separated on the basis of their relative mobilities under the influence of an electric current. The separated proteins are then permitted to diffuse through the agar toward a multispecific antiserum, allowing precipitation and visualization of the separate complexes.

• Enzyme Labeled Antinuclear Antibody (FDA Code: LJM / 866.5100) An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjogren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

• Eosin Y Stain (FDA Code: HYB / 864.1850)

• Epidermal Growth Factor Receptor Antibody Immunohistochemistry Assay (FDA Code: NQF / 864.1860) Immunohistochemistry test systems (IHC's) are in vitro diagnostic devices consisting of polyclonal or monoclonal antibodies labeled with directions for use and performance claims, which may be packaged with ancillary reagents in kits. Their intended use is to identify, by immunological techniques, antigens in tissues or cytologic specimens. Similar devices intended for use with flow cytometry devices are not considered IHC's.

• Escherichia Coli Antisera (FDA Code: GNA / 866.3255)

• Estrogen Receptor Antibody Immunohistochemistry Assay (FDA Code: MYA / 864.1860)

• Estrogen Receptor Assay Kit (FDA Code: LPJ / 864.1860)

• Factor B Antiserum (FDA Code: JZH / 866.5320) A properdin factor B immunological test system is a device that consists of the reagents used to measure by immunochemical techniques properdin factor B in serum and other body fluids. The deposition of properdin factor B in body tissues or a corresponding depression in the amount of properdin factor B in serum and other body fluids is evidence of the involvement of the alternative to the classical pathway of activation of complement (a group of plasma proteins which cause the destruction of cells which are foreign to the body). Measurement of properdin factor B aids in the diagnosis of several kidney diseases, e.g., chronic glomerulonephritis (inflammation of the glomeruli of the kidney), lupus nephritis (kidney disease associated with a multisystem autoimmune disease, systemic lupus erythematosus), as well as several skin diseases, e.g., dermititis herpetiformis (presence of vesicles on the skin that burn and itch), and pemphigus vulgaris (large vesicles on the skin). Other diseases in which the alternate pathway of complement activation has been implicated include rheumatoid arthritis, sickle cell anemia, and gram-negative bacteremia.

• Ferritin (FDA Code: DBF / 866.5340) A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.

• Fibrinogen and Fibrin Split Products (FDA Code: DAP / 864.7320) A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).

• Fibrinogen and Split Product (FDA Code: DAZ / 864.7340) A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).

• Fitc Alpha-2-Macroglobulin Antiserum Antigen Control (FDA Code: DDY / 866.5620) Analpha -2-macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -2-macroglobulin (a serum protein) in plasma. Measurement ofalpha -2-macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.

• FITC Conjugated Gamma Globulin (FDA Code: DAF / 866.5510) An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

• FITC Fibrinogen and Split Products (FDA Code: DAX / 864.7340)

• FITC IgA Antisera (FDA Code: CZN / 866.5510)

• Fluorescein-Labeled Probes

• Fluorochrome-Conjugated DNA Probes

• Free Secretory Component (FDA Code: DAJ / 866.5380) A free secretory component immunological test system is a device that consists of the reagents used to measure by immunochemical techniques free secretory component (normally a portion of the secretory IgA antibody molecule) in body fluids. Measurement of free secretory component (protein molecules) aids in the diagnosis or repetitive lung infections and other hypogammaglobulinemic conditions (low antibody levels).

• Gamma Chain Specific Control (FDA Code: DFZ / 866.5510)

• Gamma Globulin (FDA Code: DAH / 866.5510)

• General Purpose Reagent (FDA Code: LDT)

• General Virus Reagent

• Giemsa Stain (FDA Code: HYF / 864.1850)

• Globulin Electrophoretic (FDA Code: CGH / 862.1330) A globulin test system is a device intended to measure globulins (proteins) in plasma and serum. Measurements of globulin are used in the diagnosis and treatment of patients with numerous illnesses including severe liver and renal disease, multiple myeloma, and other disorders of blood globulins.

• Haptoglobin (FDA Code: DAD / 866.5460) A haptoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the haptoglobin (a protein that binds hemoglobin, the oxygen-carrying pigment in red blood cells) in serum. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and release hemoglobin) related to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases.

• Hematology Stain (FDA Code: KQC / 864.1850)

• Hematoxylin Stain (FDA Code: HYJ / 864.1850)

• Hemopexin (FDA Code: CZX / 866.5490)

• Hepatitis B Antigen Identification System (FDA Code: KSJ)

• Histology Crystal Violet Stain (FDA Code: ICF / 864.1850)

• Human and Animal Sera (FDA Code: KIS / 864.2800) Animal and human sera are biological products, obtained from the blood of humans or other animals, that provide the necessary growth-promoting nutrients in a cell culture system.

• Human Chorionic Gonadotropin Test

• Human Papillomavirus DNA Probes

• Human Placental Lactogen Test

• Hybridization Instruments

• IFA Antibody Antigen Respiratory Syncytial Virus (FDA Code: LKT / 866.3480) Respiratory syncytial virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to respiratory syncytial virus in serum. Additionally, some of these reagents consist of respiratory syncytial virus antisera conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify respiratory syncytial viruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of respiratory syncytial virus infections and provides epidemiological information on diseases caused by these viruses. Respiratory syncytial viruses cause a number of respiratory tract infections, including the common cold, pharyngitis, and infantile bronchopneumonia.

• IGA Control (FDA Code: CZP / 866.5510)

• IgD Antisera (FDA Code: CZJ / 866.5510)

• IgE Control (FDA Code: DGC / 866.5510)

• IgG Control (FDA Code: DEW / 866.5510)

• Ihc Her-2/Neu Test System (FDA Code: MVC)

• Immunochemical, Lysozyme (FDA Code: JMR / 862.1490) A lysozyme (muramidase) test system is a device intended to measure the activity of the bacteriolytic enzyme lysozyme (muramidase) in serum, plasma, leukocytes, and urine. Lysozyme measurements are used in the diagnosis and treatment of monocytic leukemia and kidney disease.

• Immunoelectrophoretic, Immunoglobulins (G, A, M) (FDA Code: CFF / 866.5510)

• Immunoglobulin G FC Fragment Specific Antisera (FDA Code: DAS / 866.5530) An immunoglobulin G (Fc fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fc (carbohydrate containing) fragment of immunoglobulin G (resulting from breakdown of immunoglobulin G antibodies) in urine, serum, and other body fluids. Measurement of immunoglobulin G Fc fragments aids in the diagnosis of plasma cell antibody-forming abnormalities, e.g., gamma heavy chain disease.

• Immunoglobulin M (IgM) (FDA Code: DFT / 866.5550) An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.

• Immunohistochemistry Reagents And Kits (FDA Code: NJT / 864.1860)

• Indigocarmine Stain (FDA Code: KJT / 864.1850)