Profile: DiaSorin S.p.A. creates & manufactures reagents for in vitro diagnostics. Our products are available in RIA, elisa and Liaison® formats that include markers for breast, ovarian, colorectal, stomach, pancreas, lung, prostate, bladder, germ cells, skin & thyroid cancers. Our Liaison® Troponin I offers a high degree of analytical and clinical reliability for troponin testing. We offer a comprehensive range of immunoassays for the assessment of bone & mineral metabolism including advanced diagnostic tools, such as 25-OH Vitamin D and 1,25(OH)2 Vitamin D assays. We also offer tests for the measurement of autoantibodies to thyroglobulin and thyroid peroxidase, providing efficient tools for the diagnosis of thyroid autoimmune diseases.

The company has revenues of USD 50-100 Million and is ISO 9001, CE certified.

FDA Registration Number: 9616669
US Agent: John C. Walter / Diasorin Inc.
Phone: +1-(651)-439-9710  Fax: +1-(651)-351-5669  E-Mail:

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• FAB Fragment Specific Control (FDA Code: DFK / 866.5520) An immunoglobulin G (Fab fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fab antigen-binding fragment resulting from breakdown of immunoglobulin G antibodies in urine, serum, and other body fluids. Measurement of Fab fragments of immunoglobulin G aids in the diagnosis of lymphoproliferative disorders, such as multiple myeloma (tumor of bone marrow cells), Waldenstrom's macroglobulinemia (increased immunoglobulin production by the spleen and bone marrow cells), and lymphoma (tumor of the lymphoid tissues).

• Factor B Antiserum (FDA Code: JZH / 866.5320) A properdin factor B immunological test system is a device that consists of the reagents used to measure by immunochemical techniques properdin factor B in serum and other body fluids. The deposition of properdin factor B in body tissues or a corresponding depression in the amount of properdin factor B in serum and other body fluids is evidence of the involvement of the alternative to the classical pathway of activation of complement (a group of plasma proteins which cause the destruction of cells which are foreign to the body). Measurement of properdin factor B aids in the diagnosis of several kidney diseases, e.g., chronic glomerulonephritis (inflammation of the glomeruli of the kidney), lupus nephritis (kidney disease associated with a multisystem autoimmune disease, systemic lupus erythematosus), as well as several skin diseases, e.g., dermititis herpetiformis (presence of vesicles on the skin that burn and itch), and pemphigus vulgaris (large vesicles on the skin). Other diseases in which the alternate pathway of complement activation has been implicated include rheumatoid arthritis, sickle cell anemia, and gram-negative bacteremia.

• Fibrinogen Determination System Test (FDA Code: KQJ / 864.7340) A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).

• Fibrinogen Test (FDA Code: GIS / 864.7340)

• FITC IgA Antisera (FDA Code: CZN / 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.

• Follicle Stimulating Hormone Radioimmunoassay (FDA Code: CGJ / 862.1300) A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.

• Gastrin Radioimmunoassay Test (FDA Code: CGC / 862.1325) A gastrin test system is a device intended to measure the hormone gastrin in plasma and serum. Measurements of gastrin are used in the diagnosis and treatment of patients with ulcers, pernicious anemia, and the Zollinger-Ellison syndrome (peptic ulcer due to a gastrin-secreting tumor of the pancreas).

• Gelatin for Specimen Adhesion (FDA Code: IFZ / 864.4010)

• General Diagnostic Supplies

• General Diagnostics

• General Medical Supplies

• Haematology and Immunoassay Analyzers

• Haptoglobin (FDA Code: DAD / 866.5460) A haptoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the haptoglobin (a protein that binds hemoglobin, the oxygen-carrying pigment in red blood cells) in serum. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and release hemoglobin) related to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases.

• Hepatitis A Test (FDA Code: LOL / 866.3310) HAV serological assays are devices that consist of antigens and antisera for the detection of hepatitis A virus-specific IgM, IgG, or total antibodies (IgM and IgG), in human serum or plasma. These devices are used for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis to determine if an individual has been previously infected with HAV, or as an aid to identify HAV-susceptible individuals. The detection of these antibodies aids in the clinical laboratory diagnosis of an acute or past infection by HAV in conjunction with other clinical laboratory findings. These devices are not intended for screening blood or solid or soft tissue donors.

• Hepatitis B Antigen Identification System (FDA Code: KSJ)

• Hepatitis B Test (FDA Code: LOM)

• HSV-1 Herpes Simplex Virus Enzyme-Linked Immunosorbent Assay (FDA Code: MXJ / 866.3305)

• HSV-2 Herpes Simplex Virus Enzyme-Linked Immunosorbent Assay (FDA Code: MYF / 866.3305)

• Human Growth Hormone Radioimmunoassay (FDA Code: CFL / 862.1370) A human growth hormone test system is a device intended to measure the levels of human growth hormone in plasma. Human growth hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland.

• Human Placental Lactogen Radioimmunoassay (FDA Code: JMF / 862.1585) A human placental lactogen test system is a device intended to measure the hormone human placental lactogen (HPL), (also known as human chorionic somatomammotrophin (HCS)), in maternal serum and maternal plasma. Measurements of human placental lactogen are used in the diagnosis and clinical management of high-risk pregnancies involving fetal distress associated with placental insufficiency. Measurements of HPL are also used in pregnancies complicated by hypertension, proteinuria, edema, post-maturity, placental insufficiency, or possible miscarriage.

• IGA Control (FDA Code: CZP / 866.5510)

• IgG Control (FDA Code: DEW / 866.5510)

• Immuno Chemistry Analyzers

• Immunoassay Analyzers

• Immunoassay Equipment, Immunochemistry Analyzers

• Immunoassay Reagents & Test Kits

• Immunoassays

• Immunoglobulin G FC Fragment Specific Antisera (FDA Code: DAS / 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.

• Immunoglobulin M (IgM) (FDA Code: DFT / 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.

• Immunological Anticardiolipin Test System (FDA Code: MID / 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).

• Immunoreactive Insulin Radioimmunoassay Test (FDA Code: CFP / 862.1405) An immunoreactive insulin test system is a device intended to measure immunoreactive insulin in serum and plasma. Immunoreactive insulin measurements are used in the diagnosis and treatment of various carbohydrate metabolism disorders, including diabetes mellitus, and hypoglycemia.

• Indirect Immunofluorescent Multiple Auto Antibody (FDA Code: DBL / 866.5660)

• Infectious Disease Identification Test Kits

• Instruments, Immunoassays

• 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.

• Laboratory Automation Systems

• Micro Chemistry Analyzer (FDA Code: JJF / 862.2170) A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.

• 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.

• Nephelometer (FDA Code: JZW / 866.4540) Immunonephelometer equipment for clinical use with its electrical power supply is a device that measures light scattering from antigen-antibody complexes. The concentration of these complexes may be measured by means of reflected light. A beam of light passed through a solution is scattered by the particles in suspension. The amount of light is detected by a photodetector, which converts light energy into electrical energy. The amount of electrical energy registers on a readout system such as a digital voltmeter or a recording chart. This electrical readout is called the light-scattering value and is used to measure the concentration of antigen-antibody complexes. This generic type of device includes devices with various kinds of light sources, such as laser equipment.

• Parathyroid Hormone Radioimmunoassay Test (FDA Code: CEW / 862.1545) A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.

• Peroxidase IgA Antisera (FDA Code: CZL / 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.

• Prealbumin (FDA Code: DDS / 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.

• Prealbumin Antiserum (FDA Code: JZJ / 866.5060)

• Progesterone Radioimmunoassay Test (FDA Code: JLS / 862.1620) A progesterone test system is a device intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.

• Prolactin Radioimmunoassay (FDA Code: CFT / 862.1625) A prolactin (lactogen) test system is a device intended to measure the anterior pituitary polypeptide hormone prolactin in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.

• Publications

• Publications Service

• Rabbit Digoxin (125-I) Antibody Radioimmunoassay Test (FDA Code: DPB / 862.3320) A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

• Radioimmunoassay For Cyclosporine (FDA Code: MGV / 862.1235) A cyclosporine test system is a device intended to quantitatively determine cyclosporine concentrations as an aid in the management of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and chromatographic assays for cyclosporine.