Biomerieux Industry

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Contact: Emil Ulstrup - Director of Marketing & Sales
Web: http://www.biomerieux-usa.com
E-Mail:
Address: 595 Anglum Road, Hazelwood, Missouri 63042-2320, USA
Phone: +1-(314)-731-8500, 800-634-7656 | Fax: +1-(314)-731-8678 | Map/Directions >>
 
 

Profile: Biomerieux Industry provides in vitro diagnostics solutions for medical and industrial applications. We assist in the diagnosis of infectious diseases, such as hepatitis, HIV, tuberculosis and respiratory infections, as well as pathologies such as cardiovascular diseases or cancer, based on the analysis of biological sample. We offer a broad range of solutions for clinical laboratories clinicians and administrators, physician's office laboratory and medical conditions. We provide WorkSafe™ blood culture collection kits, PNA FISH™, DiversiLab™ system, Vidas® difficile toxin A & B for rapid detection of C. difficile, chromID™ and ICNet software. The DiversiLab systems for tracking the spread and source of microbial contamination & infection or epidemics outbreaks, based on patented rep-PCR technology, microbial isolates accurately at the subspecies and strain level.

The company was founded in 1994, has revenues of USD 1-5 Million, has ~40 employees and is CE certified.

FDA Registration Number: 8020790
US Agent: Jolyn Tenllado / Biomerieux, Inc.
Phone: +1-(314)-731-8386  Fax: +1-(314)-731-8689  E-Mail:

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• Acetone
• Acid Fuchsin Stain (FDA Code: IDF / 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.
• Acid, Hydroxyazobenzene-Benzoic, Albumin (FDA Code: CJZ / 862.1035)
An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
• Acquired Immune Deficiency Syndrome (AIDS) Antibody Test
• Air Bubble Detectors (FDA Code: FJF / 876.5820)
A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.
• Air Bubble Monitor (FDA Code: FJF / 876.5820)
• Albumin Tetrabromo-M-Cresolsulfonphthalein Test (FDA Code: CJG / 862.1035)
• Alkaline Phosphatase (ALP) (FDA Code: JCJ / 864.7660)
A leukocyte alkaline phosphatase test is a device used to identify the enzyme leukocyte alkaline phosphatase in neutrophilic granulocytes (granular leukocytes stainable by neutral dyes). The cytochemical identification of alkaline phosphatase depends on the formation of blue granules in cells containing alkaline phosphatase. The results of this test are used to differentiate chronic granulocytic leukemia (a malignant disease characterized by excessive overgrowth of granulocytes in the bone marrow) and reactions that resemble true leukemia, such as those occuring in severe infections and polycythemia (increased total red cell mass).
• Alkaline Phosphatase, Phenylphosphate Test (FDA Code: CKF / 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.
• Alkaline Picrate Creatinine Colorimetric Method (FDA Code: CGX / 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.
• Alpha-Ketobutyric Acid and NADH (FDA Code: JMK / 862.1380)
A hydroxybutyric dehydrogenase test system is a device intended to measure the activity of the enzyme alpha-hydroxybutric dehydrogenase (HBD) in plasma or serum. HBD measurements are used in the diagnosis and treatment of myocardial infarction, renal damage (such as rejection of transplants), certain hematological diseases (such as acute leukemias and megaloblastic anemias) and, to a lesser degree, liver disease.
• Amyloclastic, Amylase (FDA Code: CJA / 862.1070)
An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
• Anaerobic Identification Kit
• Anaerobic Identification Kit Test (FDA Code: JSP / 866.2660)
A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.
• Antibiotic Susceptibility Test
• Antimicrobial Susceptibility Test Culture Media (FDA Code: JSO / 866.1700)
A culture medium for antimicrobial susceptibility tests is a device intended for medical purposes that consists of any medium capable of supporting the growth of many of the bacterial pathogens that are subject to antimicrobial susceptibility tests. The medium should be free of components known to be antagonistic to the common agents for which susceptibility tests are performed in the treatment of disease.
• Antimicrobic Susceptibility Testing Device
• Apheresis Equipment
• 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.
• Automated Blood Grouping and Antibody Test System (FDA Code: KSZ / 864.9175)
An automated blood grouping and antibody test system is a device used to group erythrocytes (red blood cells) and to detect antibodies to blood group antigens.
• Automated Coagulation Analyzer (FDA Code: GKP / 864.5400)
A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.
• Automated Coagulation Instrument (FDA Code: GKP / 864.5400)
• Automated Enzyme Immunoassay Analyzers
• Automated Hematology Analyzers
• Automated Immunoassay Analyzers
• Automated Microbial Detection System
• Bacterial Diagnostic Test
• Bilirubin Diazo Colorimetry Test (FDA Code: CIG / 862.1110)
A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
• Bleeding Time Device (FDA Code: JCA / 864.6100)
A bleeding time device is a device, usually employing two spring-loaded blades, that produces two small incisions in the patient's skin. The length of time required for the bleeding to stop is a measure of the effectiveness of the coagulation system, primarily the platelets.
• Blood Clot Coagulation Analyzer (FDA Code: GKP / 864.5400)
• 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 Culturing System (FDA Code: MDB / 866.2560)
A microbial growth monitor is a device intended for medical purposes that measures the concentration of bacteria suspended in a liquid medium by measuring changes in light scattering properties, optical density, electrical impedance, or by making direct bacterial counts. The device aids in the diagnosis of disease caused by pathogenic microorganisms.
• Blood Urea Nitrogen (BUN) Reagent
• Bromcresol Green Dye-Binding, Albumin (FDA Code: CIX / 862.1035)
• C-Reactive Protein (CRP), FITC Conjugate (FDA Code: DCK / 866.5270)
A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.
• C-Reactive Protein Test System (FDA Code: DCN / 866.5270)
• 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).
• Campylobacter Pylori (FDA Code: LYR / 866.3110)
• 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.
• 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.
• Coagulation Analyzer with Timer (FDA Code: GKP / 864.5400)
• Coagulation Analyzers (FDA Code: GKP / 864.5400)
• Coagulation Factor Deficient Plasma (FDA Code: GJT / 864.7290)
A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).
• Coagulation Lab Testing
• 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.
• Computer Softwares
• Coombs Control
• Cortisol Fluorometric Test (FDA Code: JFT / 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.
• CPK Isoenzymes Chromatographic Separation Test (FDA Code: JHT / 862.1215)
A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
• Creatine Phosphate Kinase Reagent Test

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