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Hemagen Diagnostics, Inc.

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Contact: William P. Hales - President
Web: http://www.hemagen.com
E-Mail:
Address: 9033 Red Branch Road, Columbia, Maryland 21045, USA
Phone: +1-(443)-367-5500 | Fax: +1-(410)-997-7812 | Map/Directions >>
 
 

Profile: Hemagen Diagnostics, Inc. offers diagnostic test kits. We develop, manufacture and supply test kits used in the diagnosis of certain autoimmune & infectious diseases. Our Virgor ENA screen 6 kit is an enzyme-linked immunosorbent assay designed to detect antibodies to extractable nuclear antigens (ENA) in human serum. Our Virgor cardiolipin IgA antibody kit is an enzyme-linked immunosorbent assay which is designed for the quantitative measurement of circulating IgA autoantibodies to cardiolipin.

OTC:HMGN (SEC Filings)

FDA Registration Number: 1181055

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• Calcium
• Calcium Cresolphthalein Complexone Test (FDA Code: CIC / 862.1145)
A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
• Calcium liquid Reagent
• Calcium Phosphate Bone Cements
• Calcium Reagent
• Calcium Reagent Set
• Calcium Rinse Solution Kit
• Capillary Adapter Cleaning Kit
• Carbon-Dioxide Enzymatic (FDA Code: KHS / 862.1160)
A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
• Cardiolipin Antibody Kit
• Cardiolipin Screen Kit
• Centrifugal Chemistry Analyzer (FDA Code: JJG / 862.2140)
A centrifugal chemistry analyzer for clinical use is an automatic device intended to centrifugally mix a sample and a reagent and spectrophotometrically measure concentrations of the sample constituents. This device is intended for use in conjunction with certain materials to measure a variety of analytes.
• Chemistry Analyzers
• Chlamydia Trachomatis Fluorescent Antiserum (FDA Code: LJP / 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).
• Chloride Test System (FDA Code: CHJ / 862.1170)
A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
• Cholesterol
• Cholesterol (Single reagent)
• Cholesterol and Triglycerides Kits
• Cholesterol Colorimetric Test (FDA Code: CGO / 862.1175)
A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
• Cholesterol Home Testing Kits
• Cholesterol Monitor Kit
• Cholesterol Rapid Liquid Reagent
• cholesterol self-test kit
• Cholesterol Test Kits
• Cholesterol Testing and Cholesterol Monitoring Kits
• Clinical Immunochemistry Analyzers
• Colorimetric Uric Acid Test (FDA Code: KNK / 862.1775)
A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
• Continuous Glucose Monitoring System
• Continuous Glucose Monitoring System (CGMS System)
• Control Antigen Antinuclear Antibody (FDA Code: LKJ / 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).
• Control Antiserum Antigen FITC Thyroglobulin (FDA Code: DDJ / 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.
• Controls for Diagnostic Equipment
• Creatine Kinase (FDA Code: JLB / 862.1210)
A creatine test system is a device intended to measure creatine (a substance synthesized in the liver and pancreas and found in biological fluids) in plasma, serum, and urine. Measurements of creatine are used in the diagnosis and treatment of muscle diseases and endocrine disorders including hyperthyroidism.
• Creatinine
• Creatinine Enzymatic Method Test (FDA Code: JFY / 862.1225)
A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
• Creatinine Microalbumin Reagent Strips
• Creatinine Test Kit, enzymatic
• Creatinine Test Kit, liquid reagents
• Cytochemical, Acid Phosphatase (FDA Code: JCI / 864.1850)
Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.
• Cytomegalovirus CF Antigen (FDA Code: GQH / 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.
• Cytomegalovirus Virus IF Antibody Igm Test (FDA Code: LKQ / 866.3175)
• Determination Of Alkaline Phosphatase
• Diagnostic Kits, AST (SGOT)
• Enzymatic Esterase-Oxidase, Cholesterol (FDA Code: CHH / 862.1175)
• Enzyme Immunoassay
• Epstein-Barr Virus CF Antiserum (FDA Code: GNP / 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).
• Fluorescent Antibody for FTA-ABS Test Antiserum (FDA Code: GMX / 866.3830)
• Fluorometric Calcium (FDA Code: JFO / 862.1145)
• FTA-ABS Test Anti-Human Globulin (FDA Code: GMS / 866.3830)
• Gamma GT KIT

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