Profile: Aesku.Diagnostics is an instrument manufacturing company, responsible for the development & manufacturing of the Helmed® processor. We develop, manufacture & supply in-vitro diagnostic kits for the early detection, diagnosis & prognosis of autoimmune diseases. We also offer autoimmunity IVD panel. Aeskulisa® product range is used for innovative ELISA tests to diagnose autoimmune diseases. Aeskulisa gastroenterology panel offers kits for the diagnosis of Celiac, Crohns disease, Ulcerative Colitis and Pernicious Anaemia. Aeskuslides® provides with a panel of cell & tissue slides necessary to complete autoimmune diagnostics. Helmed® is an open instrument combining both ELISA and IFA.
The company was founded in 2003 and is ISO13485:2003 certified.
FDA Registration Number: 3003825930
US Agent: Bruno Larida / Aesku Inc.
Phone: +1-(510)-685-0189 E-Mail:
10 Products/Services (Click for related suppliers)
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• Antigen and Control Anti-DNA Antibody (FDA Code: LSW / 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). |
• Antigen And Control Extractable Antinuclear Antibody (FDA Code: LLL / 866.5100) |
• Antineutrophil Cytoplasmic Antibodies (ANCA) Test System (FDA Code: MOB / 866.5660) A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies). |
• Endomysial Autoantibodies (FDA Code: MVM / 866.5660) |
• Enzyme Labeled Antinuclear Antibody (FDA Code: LJM / 866.5100) |
• Gliadin Antibodies (FDA Code: MST / 866.5750) A radioallergosorbent immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the allergen antibodies (antibodies which cause an allergic reaction) specific for a given allergen. Measurement of specific allergen antibodies may aid in the diagnosis of asthma, allergies, and other pulmonary disorders. |
• Immunological Anticardiolipin Test System (FDA Code: MID / 866.5660) |
• Multi-Analyte Controls Unassayed (FDA Code: OHQ / 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. |
• Pipetting and Diluting Station (FDA Code: JQW / 862.2750) A pipetting and diluting system for clinical use is a device intended to provide an accurately measured volume of liquid at a specified temperature for use in certain test procedures. This generic type of device system includes serial, manual, automated, and semi-automated dilutors, pipettors, dispensers, and pipetting stations. |
• Saccharomyces Cerevisiae (S.Cerevisiae) Antibodies (FDA Code: NBT / 866.5785) The Anti-Saccharomyces cerevisiae (S. cerevisiae ) antibody (ASCA) test system is an in vitro diagnostic device that consists of the reagents used to measure, by immunochemical techniques, antibodies toS. cerevisiae (baker's or brewer's yeast) in human serum or plasma. Detection ofS. cerevisiae antibodies may aid in the diagnosis of Crohn's disease. |