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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• Secondary Calibrator (FDA Code: JIT / 862.1150) A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also 862.2 in this part.)

• Silver Nitrate (FDA Code: HZX / 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.

• Specimen/Tissue Identification Orientation System (FDA Code: MJI / 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.

• Tissue Cassette (FDA Code: IDZ / 864.3010)

• Tissue Staining Systems

• Transferrin Antigen (FDA Code: DDG / 866.5880) A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

• Whole Blood Plasma (FDA Code: DGQ / 866.5700) A whole human plasma or serum immunological test system is a device that consists of reagents used to measure by immunochemical techniques the proteins in plasma or serum. Measurements of proteins in plasma or serum aid in the diagnosis of any disease concerned with abnormal levels of plasma or serum proteins, e.g., agammaglobulinemia, allergies, multiple myeloma, rheumatoid vasculitis, or hereditary angioneurotic edema.

• Whole Human Serum (FDA Code: DGR / 866.5700)