Profile: Quest International, Inc. is a developer and manufacturer of diagnostic reagents. We develop and manufacture in vitro diagnostic products, for the serology & immunology laboratory. Our products are designed for use with many automated analyzers or for manual use. We provide in vitro diagnostic products to the clinical laboratory community. We develop in vitro diagnostic enzyme immunoassays for the diagnosis and management of infectious & autoimmune diseases.
FDA Registration Number: 1061839
20 Products/Services (Click for related suppliers)
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• Anti-SM-Antibody (FDA Code: LKP / 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) |
• Autoimmune Test Kits |
• Campylobacter Pylori (FDA Code: LYR / 866.3110) |
• Cytomegalovirus Enzyme Linked Immunoabsorbent Assay (FDA Code: LFZ / 866.3175) Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome. |
• Enzyme Labeled Anti-DNA Antibody (FDA Code: LRM / 866.5100) |
• Enzyme Labeled Antinuclear Antibody (FDA Code: LJM / 866.5100) |
• Epstein-Barr Virus (FDA Code: LSE / 866.3235) Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer). |
• Epstein-Barr Virus IF Antibody IGM (FDA Code: LJN / 866.3235) |
• Herpes Simplex Virus Enzyme Linked Immunoabsorbent Assay (FDA Code: LGC / 866.3305) |
• 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). |
• Infectious Disease Test Kits |
• Mumps Virus Enzyme Linked Immunoabsorbent Assay (FDA Code: LJY / 866.3380) Mumps virus serological reagents consist of antigens and antisera used in serological tests to identify antibodies to mumps virus in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used in serological tests to identify mumps viruses from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of mumps and provides epidemiological information on mumps. Mumps is an acute contagious disease, particularly in children, characterized by an enlargement of one or both of the parotid glands (glands situated near the ear), although other organs may also be involved. |
• Rubella Enzyme Linked Immunoabsorbent Assay (FDA Code: LFX / 866.3510) Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome). |
• Rubeola Enzyme Linked Immunoabsorbent Assay (FDA Code: LJB / 866.3520) Rubeola (measles) virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubeola virus in serum. The identification aids in the diagnosis of measles and provides epidemiological information on the disease. Measles is an acute, highly infectious disease of the respiratory and reticuloendothelial tissues, particularly in children, characterized by a confluent and blotchy rash. |
• Thyroglobulin (FDA Code: DDC / 866.5870) A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid. |
• Thyroid Autoantibody Test System (FDA Code: JZO / 866.5870) |
• Toxoplasma Gondii Enzyme Linked Immunoabsorbent Assay (FDA Code: LGD / 866.3780) |
• Treponema Pallidum Enzyme Linked Immunoabsorbent Assay (FDA Code: LIP / 866.3830) |
• Varicella-Zoster Enzyme Linked Immunoabsorbent Assay (FDA Code: LFY / 866.3900) Varicella-zoster virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to varicella-zoster in serum. The identification aids in the diagnosis of diseases caused by varicella-zoster viruses and provides epidemiological information on these diseases. Varicella (chicken pox) is a mild, highly infectious disease, chiefly of children. Zoster (shingles) is the recurrent form of the disease, occurring in adults who were previously infected with varicella-zoster viruses. Zoster is the response (characterized by a rash) of the partially immune host to a reactivation of varicella viruses present in latent form in the patient's body. |