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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• Inter-Alpha Trypsin Inhibitor Control (FDA Code: CZO / 866.5890) An inter-alpha trypsin inhibitor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the inter-alpha trypsin inhibitor (a protein) in serum and other body fluids. Measurement of inter-alpha trypsin inhibitor may aid in the diagnosis of acute bacterial infection and inflammation.

• Iron Stain (FDA Code: GGH / 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.

• Kappa FITC (FDA Code: DEO / 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.

• Labeled Medical Laboratory Equipment (FDA Code: LXG / 862.2050) General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.

• Lactoferrin (FDA Code: DEG / 866.5570) A lactoferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the lactoferrin (an iron-binding protein with the ability to inhibit the growth of bacteria) in serum, breast milk, other body fluids, and tissues. Measurement of lactoferrin may aid in the diagnosis of an inherited deficiency of this protein.

• Lambda Antiserum (FDA Code: DEH / 866.5550)

• Lambda Chain FITC Antibody (FDA Code: DES / 866.5550)

• Lectins and Protectins (FDA Code: KSI / 864.9550) Lectins and protectins are proteins derived from plants and lower animals that cause cell agglutination in the presence of certain antigens. These substances are used to detect blood group antigens for in vitro diagnostic purposes.

• Light Green Stain (FDA Code: HYS / 864.1850)

• Luteinizing Hormone

• Lymphocyte Typing Control

• Lysozyme

• Mayer's Hematoxylin Stain (FDA Code: HYL / 864.1850)

• Methenamine Silver Stain (FDA Code: HYZ / 864.1850)

• Methyl Green Stain (FDA Code: HZA / 864.1850)

• Microscope Slide Coverslip (FDA Code: KES / 864.3010) Tissue processing equipment consists of devices used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.

• Microscope Slides (FDA Code: KEW / 864.3010)

• Microscope Slides (FDA Code: KEW / 864.3010)

• Monoclonal Antibody Cancer Detection Test

• Monoclonal Antibody Test

• Mounting Media (FDA Code: LEB / 864.4010)

• Mu-chain Specific Antisera (FDA Code: DAO / 866.5550)

• Mucicarmine Stain (FDA Code: HZC / 864.1850)

• Myelin Basic Protein RIA Kit

• Myoglobin (FDA Code: DDR / 866.5680) A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

• Nuclear Fast Red Stain (FDA Code: HZF / 864.1850)

• Nucleic Acid Or Serum Her-2/Neu Test System (FDA Code: MVD)

• Operator Intervention Automated Image Analysis Microscope (FDA Code: NOT / 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.

• Peroxidase Anti-Peroxidase Immunohistochemical Stain (FDA Code: LIJ / 864.4400) Enzyme preparations are products that are used in the histopathology laboratory for the following purposes:

• Peroxidase Antiserum (FDA Code: DFD / 866.5550)

• Peroxidase Conjucated IgG (FDA Code: DAA / 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.

• Peroxidase Conjugated IgM Antiserum (FDA Code: DEY / 866.5550)

• Peroxidase IgA Antisera (FDA Code: CZL / 866.5510)

• Peroxidase Lambda Antiserum Antigen Control (FDA Code: DEP / 866.5550)

• Peroxidase-conjugated Anti-IgD (FDA Code: DGH / 866.5510)

• Peroxidase-conjugated Anti-IgE (FDA Code: DGO / 866.5510)

• Plasminogen (FDA Code: DDX / 866.5715) A plasminogen immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the plasminogen (an inactive substance from which plasmin, a blood-clotting factor, is formed) in serum, other body fluids, and tissues. Measurement of plasminogen levels may aid in the diagnosis of fibrinolytic (blood-clotting) disorders.

• Pneumocystis Carinii (FDA Code: LYF / 866.3780)

• Prealbumin Antiserum (FDA Code: JZJ / 866.5060) A prealbumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the prealbumin (a plasma protein) in serum and other body fluids. Measurement of prealbumin levels in serum may aid in the assessment of the patient's nutritional status.

• Progesterone Receptor Antibody Immunohistochemistry Assay (FDA Code: MXZ / 864.1860)

• Progesterone Receptor Assay Kit (FDA Code: LPI / 864.1860)

• Prothrombin Antigen (FDA Code: DDF / 866.5735) A prothrombin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the prothrombin (clotting factor II) in serum. Measurements of the amount of antigenically competent (ability to react with protein antibodies) prothrombin aid in the diagnosis of blood-clotting disorders.

• Red Cell Lysing Fluid (FDA Code: GGK / 864.8540) A red cell lysing reagent is a device used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells.

• Retinol-Binding Protein (FDA Code: CZS / 866.5765) A retinol-binding protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the retinol-binding protein that binds and transports vitamin A in serum and urine. Measurement of this protein may aid in the diagnosis of kidney disease and in monitoring patients with kidney transplants.

• Rhodamine Antiserum (FDA Code: CZK / 866.5510)

• Rhodamine-conjugated Anti-IgD (FDA Code: DGE / 866.5510)

• Rhodamine-conjugated Anti-IgM (FDA Code: DEZ / 866.5550)

• Rhodamine-conjugated Antisera (FDA Code: DFG / 866.5550)

• Schiff Reagent Stain (FDA Code: HZT / 864.1850)

• Secondary Antibody Test (FDA Code: KTS / 866.5510)