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

151 to 200 of 214 Products/Services (Click for related suppliers)  Page: 1 2 3 [4] 5

• Microalbuminuria Testing Kits

• Minerals, Calcium

• Minerals, Magnesium

• Mouse Anti-Human Prostatic Acid Phosphatase (PSAP) Detection Kit

• Mouse Stomach Test System

• 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.

• Multi Analyte Mixture - Calibrator (FDA Code: JIX / 862.1150) A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also 862.2 in this part.)

• Multichannel Hematology Analyzers

• Mumps Virus Fluorescent Antiserum Test (FDA Code: GRA / 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.

• NAD/NADH Reagent for Alcohol Enzume Method (FDA Code: DML / 862.3040) An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.

• Nadh Oxidation/Nad Reduction (FDA Code: CKA / 862.1030) An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

• Nephelometric Method for Immunoglobulins G, A, M (FDA Code: CFN / 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.

• Nitrophenylphosphate, Alkaline Phosphatase (FDA Code: CJE / 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.

• Non Invasive Glucose Monitoring

• Noninvasive Blood Glucose Monitors

• Pancreatic Amylase

• PAP Prostatic Acid Phosphatase (ELISA Kits)

• Phosphorous

• Powdered Phosphate Buffer

• Primary Calibrator (FDA Code: JIS / 862.1150)

• Prostatic Acid Phosphatase

• Psittacosis CF Antigen (FDA Code: GPW / 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).

• Pyrex Test Tubes

• Quantitative Kinetic Determination Of Amylase Kit

• Radioimmunoassay Kit For Prostatic Acid Phosphatase

• Red Dye Test Solution

• Refurbished Hematology Analyzers

• Rheumatoid Factor Test System (FDA Code: DHR / 866.5775) A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

• Rimmed Glass Test Tubes

• Rubella Assays (FDA Code: LSD / 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).

• Rubella Hai (Including Hai Control) Antisera (FDA Code: GOK / 866.3510)

• Rubeola Fluorescent Antiserum (FDA Code: GRE / 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.

• Salivary Amylase

• Sample Detector

• Secondary Calibrator (FDA Code: JIT / 862.1150)

• Serum Albumin Detection Kit

• Serum Amylase

• Serum Prostatic Acid Phosphatase Test Kit

• Serum Total Protein

• Smaller Hematology Analyzers

• T.Cruzi Enzyme Linked Immunoabsorbent Assay (FDA Code: MIU / 866.3870)

• Test Tubes

• Thyroid Antibody Test System

• Total Protein Biuret Method (FDA Code: CEK / 862.1635) A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.

• Total Thyroxine Non-Radiolabeled Enzyme Immunoassay (FDA Code: KLI / 862.1700) A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

• Toxoplasma Gondii IF Antigen Test (FDA Code: GLZ / 866.3780)

• Triglycerides

• Triglycerides Colorimetric Method Test (FDA Code: JGY / 862.1705) A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

• Triglycerides Lipase Hydrolysis/Glycerol Kinase Enzyme Test (FDA Code: CDT / 862.1705)

• Triglycerides Monitoring Kits