Profile: Bio-Rad Laboratories, Inc. deals with life science research, clinical diagnostics, spectroscopy, process separations, and life science education. Our clinical diagnostics category deals with products such as autoimmune, blood virus, diabetes testing, microbiology, new born screening, and instrumentation. Our CLIA-waived in2it analyzer and accessories offer point-of-care hemoglobin A1c testing for diabetes patients. Our Variantnbs hemoglobin testing system and short programs test newborn dried blood specimens for abnormal hemoglobins associated with sickle cell disease & other hemoglobin disorders.

The company has revenues of USD 500 Million to 1 Billion, has ~4300 employees and is ISO 9000, ISO 9001, CE certified. AMEX:BIO (SEC Filings)

FDA Registration Number: 2915274

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• 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).

• Erythrocyte Sedimentation Rate Test (FDA Code: JPH / 864.6700) An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a device that measures the degree of sedimentation taking place in a given length of time. An increased rate indicates tissue damage or inflammation.

• Estriol Radioimmunoassay Test (FDA Code: CGI / 862.1265) An estriol test system is a device intended to measure estriol, an estrogenic steroid, in plasma, serum, and urine of pregnant females. Estriol measurements are used in the diagnosis and treatment of fetoplacental distress in certain cases of high-risk pregnancy.

• Ferritin Radioimmunoassay Test (FDA Code: JMG / 866.5340) A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.

• Filter Gel

• Filter Pipette Tips

• Folic Acid Radioimmunoassay (FDA Code: CGN / 862.1295) A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.

• Follicle Stimulating Hormone Radioimmunoassay (FDA Code: CGJ / 862.1300) A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.

• Galactose Enzymatic Method Test (FDA Code: JIA / 862.1310) A galactose test system is a device intended to measure galactose in blood and urine. Galactose measurements are used in the diagnosis and treatment of the hereditary disease galactosemia (a disorder of galactose metabolism) in infants.

• Galactose-1-Phosphate Uridyltransferase (FDA Code: KQP / 862.1315) A galactose-1-phosphate uridyl transferase test system is a device intended to measure the activity of the enzyme galactose-1-phosphate uridyl transferase in erythrocytes (red blood cells). Measurements of galactose-1-phosphate uridyl transferase are used in the diagnosis and treatment of the hereditary disease galactosemia (disorder of galactose metabolism) in infants.

• Gel Electrophoresis Equipment

• General Medical Supplies

• General Purpose Reagent (FDA Code: LDT)

• Giant Test Tubes

• Glass Test Tube

• Glycosylated Hemoglobin Assay Test (FDA Code: LCP / 864.7470) A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a, A1b, and A1c) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.

• Heavy Metals Control Materials (FDA Code: DIE / 862.3280) A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

• Hematology Quality Control Mixture (FDA Code: JPK / 864.8625) A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).

• Hemoglobin A2 Quantitation Test (FDA Code: JPD / 864.7400) A hemoglobin A2assay is a device used to determine the hemoglobin A2content of human blood. The measurement of hemoglobin A2is used in the diagnosis of the thalassemias (hereditary hemolytic anemias characterized by decreased synthesis of one or more types of hemoglobin polypeptide chains).

• Hemoglobin and Hematocrit Measurement Calibrator (FDA Code: KRZ / 864.8165) A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. It is a material whose characteristics have been precisely and accurately determined.

• Hemoglobin Assay (FDA Code: LGL / 864.7500) A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.

• Hemoglobin Control (FDA Code: GGM / 864.8625)

• Hepatitis B Test (FDA Code: LOM)

• Hepatitis C Test Kit

• High Performance Liquid Chromatography Analyzer

• High Pressure Liquid Chromatography for Tricyclic Antidepressant Drugs (FDA Code: LFI / 862.3910) A tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant drugs in serum. The tricyclic antidepressant drugs include imipramine, desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin. Measurements obtained by this device are used in the diagnosis and treatment of chronic depression to ensure appropriate therapy.

• High Pressure Liquid Chromatography Instrumentation (FDA Code: LDM / 862.2260) A high pressure liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a solution by processing the mixture of compounds (solutes) through a column packed with materials of uniform size (stationary phase) under the influence of a high pressure liquid (mobile phase). Separation of the solutes occurs either by absorption, sieving, partition, or selective affinity.

• HIV Detection Test (FDA Code: MZF)

• HIV Screening - Western Blot

• HSV-1 Herpes Simplex Virus Enzyme-Linked Immunosorbent Assay (FDA Code: MXJ / 866.3305)

• HSV-2 Herpes Simplex Virus Enzyme-Linked Immunosorbent Assay (FDA Code: MYF / 866.3305)

• Hydrophilic Membrane Filter

• Hydrophobic Membrane Filter

• Immunodiffusion Equipment

• Immunofluorescence Equipment

• Indirect Immunofluorescent Antimitochondrial Antibody Test (FDA Code: DBM / 866.5090) An antimitochondrial antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own tissue), such as primary biliary cirrhosis (degeneration of liver tissue) and chronic active hepatitis (inflammation of the liver).

• Indirect Immunofluorescent Multiple Auto Antibody (FDA Code: DBL / 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 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.

• Instrumentation For Clinical Multiplex Test Systems (FDA Code: NSU / 862.2570)

• Ion Exchange Column with Colorimetry Delta-Aminolevulinic Acid (FDA Code: JKL / 862.1060) Adelta -aminolevulinic acid test system is a device intended to measure the level ofdelta -aminolevulinic acid (a precursor of porphyrin) in urine.Delta -aminolevulinic acid measurements are used in the diagnosis and treatment of lead poisoning and certain porphyrias (diseases affecting the liver, gastrointestinal, and nervous systems that are accompanied by increased urinary excretion of various heme compounds includingdelta -aminolevulinic acid).

• Ion-Exchange Chromatography (FDA Code: DJY / 862.2230) A chromatographic separation material for clinical use is a device accessory (e.g., ion exchange absorbents, ion exchagne resins, and ion papers) intended for use in ion exchange chromatography, a procedure in which a compound is separated from a solution.

• Ion-Exchange Resin, Porphobilinogen (FDA Code: JNF / 862.1590) A porphobilinogen test system is a device intended to measure porphobilinogen (one of the derivatives of hemoglobin which can make the urine a red color) in urine. Measurements obtained by this device are used in the diagnosis and treatment of porphyrias (primarily inherited diseases associated with disturbed porphyrine metabolism), lead poisoning, and other diseases characterized by alterations in the heme pathway.

• Isotachophoresis Equipment

• Labeled Medical Laboratory Equipment (FDA Code: LXG / 862.2050) General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.

• Laboratory Chart Recorder

• Laboratory Densitometer

• Laboratory Plasticware, Test Tubes

• Labware, Pipette Tip

• Labware, Test Tube

• Legionella Direct & Indirect Fluorescent Antibody Regents (FDA Code: LHL / 866.3300)