Profile: Helena Laboratories Corp. develops new diagnostic tests. We manufacture electrophoresis analyzers, test kits for fecal occult blood, immunology and protein diagnostics, and hemostasis reagents & instruments. Our quickscan 2000 uses flat-bed densitometry to image visible electrophoretic analytes on agarose gels, with the speed of windows, and the ease of Helena technology. Our AggRam analyzer includes CPU with CD burner, keyboard, mouse, color ink-jet printer and one AggRam module. It is used for platelet aggregation and ristocetin co-factor testing, and offers unsurpassed precision, ease of use and flexibility.

The company was founded in 1966, has revenues of USD 50-100 Million, has ~1000 employees and is ISO 9001, CE certified. NYSE:ASD (SEC Filings)

FDA Registration Number: 3011390138

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• Radioimmunoassay for Immunoglobulin G, A, M (FDA Code: CFQ / 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.

• Reflectance Densitometer/Scanner (FDA Code: JQT / 862.2400) A densitometer/scanner (integrating, reflectance, thin-layer chromatography, or radiochromatogram) for clinical use is device intended to measure the concentration of a substance on the surface of a film or other support media by either a photocell measurement of the light transmission through a given area of the medium or, in the case of the radiochromatogram scanner, by measurement of the distribution of a specific radio-active element on a radiochromatogram.

• Refrigerated Centrifuges (FDA Code: JQC / 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.

• Rocket Immunoelectrophoresis Equipment (FDA Code: JZX / 866.4830) Rocket immunoelectrophoresis equipment for clinical use is a device used to perform a specific test on proteins by using a procedure called rocket immunoelectrophoresis. In this procedure, an electric current causes the protein in solution to migrate through agar gel containing specific antisera. The protein precipitates with the antisera in a rocket-shaped pattern, giving the name to the device. The height of the peak (or the area under the peak) is proportional to the concentration of the protein.

• Sterile Barrier Pipette Tips

• Sterile Non-Barrier Pipette Tips

• Support Gel Test (FDA Code: JZR / 866.4900) A support gel for clinical use is a device that consists of an agar or agarose preparation that is used while measuring various kinds of, or parts of, protein molecules by various immunochemical techniques, such as immunoelectrophoresis, immunodiffusion, or chromatography.

• Thin Layer Chromatography Equipment (FDA Code: DPA / 862.2270) A thin-layer chromatography (TLC) system for clinical use is a device intended to separate one or more drugs or compounds from a mixture. The mixture of compounds is absorbed onto a stationary phase or thin layer of inert material (e.g., cellulose, alumina, etc.) and eluted off by a moving solvent (moving phase) until equilibrium occurs between the two phases.

• Thrombin Time Test (FDA Code: GJA / 864.7875) A thrombin time test is a device used to measure fibrinogen concentration and detect fibrin or fibrinogen split products for the evaluation of bleeding disorders.

• Toluidine Blue Stain (FDA Code: IAB / 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.

• Whole Human Serum (FDA Code: DGR / 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.