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

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• 2 Herpesvirus Hominis 1 Cf Antisera (FDA Code: GQO / 866.3305)

• 2 Herpesvirus Hominis 1 Fluorescent Antisera (FDA Code: GQL / 866.3305)

• Acid Fuchsin Stain (FDA Code: IDF / 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.

• Albumin Antigen Antiserum Control (FDA Code: DCF / 866.5040) An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

• Albumin, FITC Conjugate (FDA Code: DDZ / 866.5040)

• Alcian Blue Stain (FDA Code: IDA / 864.1850)

• Alpha-1-Acid-Glycoprotein Antigen (FDA Code: LKL / 866.5420) Analpha- 1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesalpha- 1-glycoproteins (a group of plasma proteins found in thealpha- 1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specificalpha- 1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.

• Alpha-1-Antichymotrypsin (FDA Code: DFF / 866.5080) Analpha -1-antichymotrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesalpha -1-antichymotrypsin (a protein) in serum, other body fluids, and tissues.Alpha -1-antichymotrypsin helps protect tissues against proteolytic (protein-splitting) enzymes released during infection.

• Alpha-1-Antitrypsin (FDA Code: DEM / 866.5130) Analpha -1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition,alpha -1-antitrypsin deficiency has been associated with pulmonary emphysema.

• Alpha-2-Macroglobulin (FDA Code: DEB / 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.

• Alpha-Fetoprotein Test

• Ammoniacal Silver Hydroxide Silver Nitrate Stain (FDA Code: ICZ / 864.1850)

• Analyte Specific Reagents, Asr Reagents (FDA Code: MVU / 864.4020) Analyte specific reagents (ASR's) are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. ASR's that otherwise fall within this definition are not within the scope of subpart E of this part when they are sold to:

• Aniline Blue Stain (FDA Code: KFD / 864.1850)

• Anti IgD FITC (FDA Code: DGG / 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.

• Anti IgE FITC (FDA Code: DGP / 866.5510)

• Anti IgG FITC (FDA Code: DGK / 866.5510)

• Anti IGG Rhodamine Conjugated (FDA Code: DFO / 866.5510)

• Anti-acetylcholine Receptor Alpha Monoclonal Antibody

• Anti-IgM FITC-Conjugated (FDA Code: DFS / 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.

• Anti-kappa Antiserum (FDA Code: DFH / 866.5550)

• Anti-kappa Rhodamine-conjugated (FDA Code: DEK / 866.5550)

• Antinuclear Antibody, Indirect Immunofluorescen (FDA Code: DHN / 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).

• Antithrombin III Control (FDA Code: DDQ / 864.7060) An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).

• Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX / 862.1660) A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

• Automated Cell-Locating Device (FDA Code: JOY / 864.5260) An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)

• Automated Slide Stainer (FDA Code: KPA / 864.3800) An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.

• Beta-2-Microglobulin Immunological Test System (FDA Code: JZG / 866.5630) Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesbeta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

• C Peptides of Proinsulin Radioimmunoassay Test (FDA Code: JKD / 862.1135) A C-peptides of proinsulin test system is a device intended to measure C-peptides of proinsulin levels in serum, plasma, and urine. Measurements of C-peptides of proinsulin are used in the diagnosis and treatment of patients with abnormal insulin secretion, including diabetes mellitus.

• C-Kit Immunohistochemistry Antibody Assay (FDA Code: NKF / 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.

• C-Reactive Protein (CRP), FITC Conjugate (FDA Code: DCK / 866.5270) A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

• Cancer Detection Test

• Carbol Fuchsin Stain (FDA Code: ICL / 864.1850)

• Carcinoembryonic Antigen Test System (FDA Code: DHX / 866.6010) A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.

• Cellular Imaging Systems

• Ceruloplasmin (FDA Code: DDB / 866.5210) A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ceruloplasmin (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.

• Complement C1q (FDA Code: DAK / 866.5240) A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q, C1r, C1s, C2, C3, C4, C5, C6, C7, C8, and C9, in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

• Complement C3 (FDA Code: CZW / 866.5240)

• Complement C4 (FDA Code: DBI / 866.5240)

• Complement C5 (FDA Code: DAY / 866.5240)

• Complement Protein (FDA Code: DHL / 866.4100) A complement reagent is a device that consists of complement, a naturally occurring serum protein from any warm-blooded animal such as guinea pigs, that may be included as a component part of serological test kits used in the diagnosis of disease.

• Congo Red Stain (FDA Code: ICH / 864.1850)

• Control Antiserum Antigen Alpha-1 Microglobulin (FDA Code: MGA / 866.5400) Analpha- globulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha- globulin (a serum protein) in serum and other body fluids. Measurement ofalpha- globulin may aid in the diagnosis of inflammatory lesions, infections, severe burns, and a variety of other conditions.

• Control Antiserum Antigen FC Test (FDA Code: DBN / 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.

• Control Antiserum Antigen Ferritin IGA (FDA Code: CZM / 866.5510)

• Control Antiserum Antigen Ferritin IGE (FDA Code: DFM / 866.5510)

• Control Antiserum Antigen Ferritin IGG (FDA Code: DGD / 866.5510)

• Control Antiserum Antigen Ferritin IGM (FDA Code: DFL / 866.5550)

• Control Antiserum Antigen FITC FC Test (FDA Code: DBK / 866.5530)

• Cystatin C Test (FDA Code: NDY / 862.1225) A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.