Profile: Quidel Corporation manufactures & markets point-of-care (POC) rapid diagnostic tests for the detection & management of a variety of medical conditions and illnesses. We concentrate on women's and family health in areas such as pregnancy, infectious diseases, general health screening, bone health & autoimmune disorders. We offer products like rapid diagnostic, SPG, reproductive health, cancer & infectious diseases. We introduced QuickVue Advance® pH and QuickVue Advance® G. vaginalis tests on the new innovative LTF™ (layered thin film) platform. LTF™ is a new proprietary technology capable of revolutionizing rapid POC testing.

The company was founded in 1979. NASDAQ:QDEL (SEC Filings)

FDA Registration Number: 1528450

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• Alkaline Phosphatase Isoenzymes Electrophoretic Separation Test (FDA Code: CIN / 862.1050) An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

• Alkaline Phosphatase, Phenylphosphate Test (FDA Code: CKF / 862.1050)

• Allergy Test

• Allergy Testing

• Amines Test Kits

• Anti-acetylcholine Receptor Alpha Monoclonal Antibody

• Antibiotic Susceptibility Test

• Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX / 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.

• Campylobacter Pylori (FDA Code: LYR / 866.3110)

• Chemistry Analyzers

• Chlamydia Group Enzyme Linked Immunoabsorbent Assay (FDA Code: LJC / 866.3120) Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusChlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).

• Chlamydia Trachomatis (FDA Code: MGM / 866.3120)

• Chlamydia trachomatis IgA ELISA Kit

• Chlamydia trachomatis IgG ELISA Kit

• Chlamydia Trachomatis IgG Kit

• Chlamydia trachomatis IgM ELISA Kit

• Chlamydia Trachomatis Real Time PCR Kit

• CIC (C1-q)

• Clinical Immunochemistry Analyzers

• Complement C1q (FDA Code: DAK / 866.5240) A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q, C1r, C1s, C2, C3, C4, C5, C6, C7, C8, and C9, in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

• Complement C1s (FDA Code: DBA / 866.5250) A complement C1inhibitor (inactivator) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C1inhibitor (a plasma protein) in serum. Complement C1inhibitor occurs normally in plasma and blocks the action of the C1component of complement (a group of serum proteins which destroy infectious agents). Measurement of complement C1inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).

• Complement C3 Activator Immunoassay Reagent (FDA Code: KTP / 866.5260) A complement C3binactivator immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C3binactivator (a plasma protein) in serum. Complement is a group of serum proteins that destroy infectious agents. Measurement of complement C3binactivator aids in the diagnosis of inherited antibody dysfunction.

• Controls

• Diagnostic Test Kits For Pregnancy

• Early Pregnancy Testing Kit

• Elisa Allergy test Kit

• Enzyme Labeled Antinuclear Antibody (FDA Code: LJM / 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).

• Fertility Monitoring Test

• Fertility Monitors, Pregnancy Test Kits

• Gardnerella Vaginalis DNA-Probe (FDA Code: MJM / 866.2660) A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

• General Diagnostic Supplies

• General Diagnostics

• General Medical Supplies

• General Surgery Supplies

• Helicobacter pylori Antibody Kits

• Home Allergy Test Kit

• Home pregnancy test kits, Hcg

• Human Chorionic Gonadotropin Radioimmunoassay (FDA Code: JHI / 862.1155) A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.

• Human Chorionic Gonadotropin Test

• Hydroxyproline Chromatography Column Test (FDA Code: JMM / 862.1400) A hydroxyproline test system is a device intended to measure the amino acid hydroxyproline in urine. Hydroxyproline measurements are used in the diagnosis and treatment of various collagen (connective tissue) diseases, bone disease such as Paget's disease, and endocrine disorders such as hyperparathyroidism and hyperthyroidism.

• Immuno Chemistry Analyzers

• Immunoassay Equipment, Immunochemistry Analyzers

• Infectious Disease Exams

• Infectious Disease Test Kits

• Infectious Mononucleosis Test System (FDA Code: KTN / 866.5640) An infectious mononucleosis immunological test system is a device that consists of the reagents used to measure by immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum, plasma, and other body fluids. Measurements of these antibodies aid in the diagnosis of infectious mononucleosis.

• Influenza A, B Test Kits

• Influenza Virus Antisera (FDA Code: GNS / 866.3330) Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic.

• Influenza Virus CF Antigen (FDA Code: GNX / 866.3330)

• Latex Allergy Test Kit

• Luteinizing Hormone