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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• Luteinizing Hormone Radioimmunoassay (FDA Code: CEP / 862.1485) A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction. |
• Lyme Disease Test |
• Monoclonal Antibody Test |
• Mononucleosis Antibody (MONO) Test Kits |
• Multi Analyte Control (FDA Code: JJY / 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. |
• Neurology Instruments |
• Occult Blood Reagent (FDA Code: KHE / 864.6550) An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.) |
• pH and Amines Test |
• Pregnancy Kits |
• Pregnancy Test Kit |
• Pregnancy Testing Kits |
• Pregnanediol Spectrophotometric Method (FDA Code: JLP / 862.1605) A pregnanediol test system is a device intended to measure pregnanediol (a major urinary metabolic product of progesterone) in urine. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta. |
• Product Development, Allergy Test Strips |
• 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. |
• Respiratory Syncytial CF Antigen (FDA Code: GQG / 866.3480) Respiratory syncytial virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to respiratory syncytial virus in serum. Additionally, some of these reagents consist of respiratory syncytial virus antisera conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify respiratory syncytial viruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of respiratory syncytial virus infections and provides epidemiological information on diseases caused by these viruses. Respiratory syncytial viruses cause a number of respiratory tract infections, including the common cold, pharyngitis, and infantile bronchopneumonia. |
• Respiratory Syncytial Virus - Elisa (FDA Code: MCE / 866.3480) |
• Sensitive Pregnancy Tests |
• Specialty Diagnostic Supplies |
• Streptococcus Spp Antigen (FDA Code: GTY / 866.3740) |
• Streptococcus Spp Antiserum (FDA Code: GTZ / 866.3740) |
• Streptococcus Test Kits |
• Swabs, Influenza A, B Test Kits |
• Swabs, Streptococcus Test Kits |
• Urinalysis Kits |
• Urinalysis Reagents & Test Strips |
• Urinary pH Dye Indicator (FDA Code: CEN / 862.1550) A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets. |
• Urine Chemistry Analyzers |
• Urine Dip Stick Chemistries |
• Urine Screening Kit (FDA Code: JXA / 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. |
• Vaginal pH and Amine Test Kits |