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
• Liquid Chromatography Equipment |
• Liquid Chromatography Ion Exchange Resins (FDA Code: DNH / 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. |
• Liquid Gel Chromatography |
• Medical Recirculating Air Cleaner (FDA Code: FRF / 880.5045) A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration. |
• Membrane Filter Holder |
• Micro Pipette (FDA Code: JRC / 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. |
• Micro Pipette Tips and Tip Racks |
• Microarray Slide Hybridization Incubator |
• Microporous Membrane Filter |
• Microtiter Diluting/Dispensing Device (FDA Code: JTC / 866.2500) A microtiter diluting and dispensing device is a mechanical device intended for medical purposes to dispense or serially dilute very small quantities of biological or chemical reagents for use in various diagnostic procedures. |
• 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.) |
• Multi-Analyte Controls Unassayed (FDA Code: OHQ / 862.1660) |
• Ninhydrin and L-Leucyl-L-Alanine Test (FDA Code: JNB / 862.1555) A phenylalanine test system is a device intended to measure free phenylalanine (an amino acid) in serum, plasma, and urine. Measurements of phenylalanine are used in the diagnosis and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation. |
• Nitrosonaphthol Test for 5-Hydroxyindole Acetic Acid Nitrous Acid (FDA Code: CDA / 862.1390) A 5-hydroxyindole acetic acid/serotonin test system is a device intended to measure 5-hydroxyindole acetic acid/serotonin in urine. Measurements of 5-hydroxyindole acetic acid/serotonin are used in the diagnosis and treatment of carcinoid tumors of endocrine tissue. |
• Non-Barrier Pipette Tip, Racked |
• Non-Propagating Transport Culture Media (FDA Code: JSM / 866.2390) A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases. |
• Non-Sterile Barrier Pipette Tips |
• Normal and Abnormal Cell Counter Control (FDA Code: JCN / 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). |
• Nucleic Acid Amplification Testing for HIV |
• P-Nitroaniline/Vanillin Vanilmandelic Acid Diazo Test (FDA Code: CDF / 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. |
• Packaging Equipment |
• Particulate Membrane Filter |
• Pipette Tip Disposal Box |
• Pipetting and Diluting Station (FDA Code: JQW / 862.2750) A pipetting and diluting system for clinical use is a device intended to provide an accurately measured volume of liquid at a specified temperature for use in certain test procedures. This generic type of device system includes serial, manual, automated, and semi-automated dilutors, pipettors, dispensers, and pipetting stations. |
• Plasma Coagulation Control (FDA Code: GGN / 864.5425) A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays. |
• Plasma Protein Analyzers |
• Plastic Test Tube |
• Plastic Test Tube Case |
• Plastic Test Tube Rack |
• Platelet Control (FDA Code: GJP / 864.8625) |
• Pneumocystis Carinii (FDA Code: LYF / 866.3780) |
• Porphyrins Fluorometric Measurement (FDA Code: JKJ / 862.1595) A porphyrins test system is a device intended to measure porphyrins (compounds formed during the biosynthesis of heme, a constituent of hemoglobin, and related compounds) in urine and feces. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning, porphyrias (primarily inherited diseases associated with disturbed porphyrin metabolism), and other diseases characterized by alterations in the heme pathway. |
• Protein Analyzer |
• Pyrex Test Tubes |
• Quality Control Kit for Blood Banking Reagents (FDA Code: KSF / 864.9650) A quality control kit for blood banking reagents is a device that consists of sera, cells, buffers, and antibodies used to determine the specificity, potency, and reactivity of the cells and reagents used for blood banking. |
• Rabbit Digoxin (125-I) Antibody Radioimmunoassay Test (FDA Code: DPB / 862.3320) A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy. |
• Racked Non-Sterile Non-Barrier Multi-Channel Pipette Tips |
• Racked Non-Sterile Non-Barrier Pipette Tips |
• Rad Helix EIA ANA Screen Bulk Kit |
• Red Cell Lysing Fluid (FDA Code: GGK / 864.8540) A red cell lysing reagent is a device used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells. |
• Respiratory Syncytial Virus Neutralization Antiserum Test (FDA Code: GQF / 866.3480) Respiratory syncytial virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to respiratory syncytial virus in serum. Additionally, some of these reagents consist of respiratory syncytial virus antisera conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify respiratory syncytial viruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of respiratory syncytial virus infections and provides epidemiological information on diseases caused by these viruses. Respiratory syncytial viruses cause a number of respiratory tract infections, including the common cold, pharyngitis, and infantile bronchopneumonia. |
• 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 |
• Rocket Immunoelectrophoresis Equipment (FDA Code: JZX / 866.4830) Rocket immunoelectrophoresis equipment for clinical use is a device used to perform a specific test on proteins by using a procedure called rocket immunoelectrophoresis. In this procedure, an electric current causes the protein in solution to migrate through agar gel containing specific antisera. The protein precipitates with the antisera in a rocket-shaped pattern, giving the name to the device. The height of the peak (or the area under the peak) is proportional to the concentration of the protein. |
• Rubella And Cmv. T.Gondii Multiplex Flow Immunoassay (FDA Code: OMI / 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). |
• Sample Injector |
• Secondary Calibrator (FDA Code: JIT / 862.1150) |
• Semi-Dry Electrophoretic Transfer Cell |
• Specialty Plasma Protein Assays |