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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• 12 Hole Test Tube Rack

• 2 Herpesvirus Hominis 1 Fluorescent Antisera (FDA Code: GQL / 866.3305)

• 3-Tiler Test Tube Stand

• Abnormal Hemoglobin Control (FDA Code: JCM / 864.7415)

• Abnormal Hemoglobin Quantitation Test (FDA Code: GKA / 864.7415)

• Amino Acid Analyzer

• Amino Acid Analyzer Reagent

• Amphetamine Liquid Chromatography Test (FDA Code: DNI / 862.3100) An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

• Anti-Ribosomal P Antibodies (FDA Code: MQA / 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).

• Anti-RNP Antibody (FDA Code: LKO / 866.5100)

• Anti-SM-Antibody (FDA Code: LKP / 866.5100)

• Antibodies to Glomerular Basement Membrane (gbm) Measure Devices (FDA Code: MVJ / 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).

• Antigen And Control Extractable Antinuclear Antibody (FDA Code: LLL / 866.5100)

• Antineutrophil Cytoplasmic Antibodies (ANCA) Test System (FDA Code: MOB / 866.5660)

• Antinuclear Antibody, Indirect Immunofluorescen (FDA Code: DHN / 866.5100)

• Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX / 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.

• Autoimmune Disease K-Nearest Neighbor Algorithm Diagnostic Software (FDA Code: NVI / 862.3100)

• Autoimmune Test Kits

• Automated For Nucleic Acid Purification

• Benzodiazepine High Pressure Liquid Chromatography Test (FDA Code: LAA / 862.3170) A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.

• Biological Monitor

• Blood Cell Diluent (FDA Code: GIF / 864.8200) A blood cell diluent is a device used to dilute blood for further testing, such as blood cell counting.

• Blood Collection Systems (FDA Code: JKA / 862.1675) A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

• Blood Gas Controls (FDA Code: JJS / 862.1660)

• Blotting Equipment

• Capillary Blood Collection Tubes (FDA Code: GIO / 864.6150) A capillary blood collection tube is a plain or heparinized glass tube of very small diameter used to collect blood by capillary action.

• Catecholamines Chromatographic/Fluorometric Method Test (FDA Code: CHQ / 862.1165) A catecholamines (total) test system is a device intended to determine whether a group of similar compounds (epinephrine, norepinephrine, and dopamine) are present in urine and plasma. Catecholamine determinations are used in the diagnosis and treatment of adrenal medulla and hypertensive disorders, and for catecholamine-secreting tumors (pheochromo-cytoma, neuroblastoma, ganglioneuroma, and retinoblastoma).

• Chlamydia Group Enzyme Linked Immunoabsorbent Assay (FDA Code: LJC / 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).

• Chlamydia Trachomatis Fluorescent Antiserum (FDA Code: LJP / 866.3120)

• Chromatography Column

• Clinical Colorimeter (FDA Code: JJQ / 862.2300) A colorimeter, a photometer, or a spectrophotometer for clinical use is an instrument intended to measure radiant energy emitted, transmitted, absorbed, or reflected under controlled conditions. The device may include a monochromator to produce light of a specific wavelength.

• Clinical Enzyme Analyzer (FDA Code: JJI / 862.2500) An enzyme analyzer for clinical use is a device intended to measure enzymes in plasma or serum by nonkinetic or kinetic measurement of enzyme-catalyzed reactions. This device is used in conjunction with certain materials to measure a variety of enzymes as an aid in the diagnosis and treatment of certain enzyme-related disorders.

• Colorimetric SGPT Test (FDA Code: CKD / 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.

• Complement C1q (FDA Code: DAK / 866.5240) A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q, C1r, C1s, C2, C3, C4, C5, C6, C7, C8, and C9, in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

• Control Antigen Antinuclear Antibody (FDA Code: LKJ / 866.5100)

• Cortisol Radioimmunoassay Test (FDA Code: CGR / 862.1205) A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.

• Cytomegalovirus (CMV) Test Kits

• Data Processing Module for Clinical use (FDA Code: JQP / 862.2100) A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data.

• Detergent (FDA Code: JCB / 864.4010)

• Discrete Photometric Chemistry Analyzer (FDA Code: JJE / 862.2160) A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.

• Disposable Pipette Tips, Non-sterile Disposable Tips

• Drug Mixture Control Materials (FDA Code: DIF / 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.

• Drug Specific Control Test (FDA Code: LAS / 862.3280)

• Electrofocusing Equipment

• Electrophoresis Instrumentation (FDA Code: JZS / 866.4500) Immunoelectrophoresis equipment for clinical use with its electrical power supply is a device used for separating protein molecules. Immunoelectrophoresis is a procedure in which a complex protein mixture is placed in an agar gel and the various proteins are separated on the basis of their relative mobilities under the influence of an electric current. The separated proteins are then permitted to diffuse through the agar toward a multispecific antiserum, allowing precipitation and visualization of the separate complexes.

• Electrophoresis Instruments

• Electrophoretic Separation, Vanilmandelic Acid (FDA Code: CDK / 862.1795) A vanilmandelic acid test system is a device intended to measure vanilmandelic acid in urine. Measurements of vanilmandelic acid obtained by this device are used in the diagnosis and treatment of neuroblastoma, pheochromocytoma, and certain hypertensive conditions.

• Enzyme Controls (FDA Code: JJT / 862.1660)

• Enzyme Labeled Anti-DNA Antibody (FDA Code: LRM / 866.5100)

• Enzyme Labeled Antinuclear Antibody (FDA Code: LJM / 866.5100)