Profile: Remel offers a wide range of microbiology products that are used in the clinical, industrial, research and academic laboratories. Our products help diagnose infection quickly and accurately, providing clinicians with information to provide proper & effective treatment. Our product category comprises of collection & transport, diagnostic tests, direct specimen tests, laboratory supplies, reagents & stains and prepared culture media. Our MicroTest™ transport products are used in the collection and transport of viruses, chlamydiae, and mycoplasma. They are available in 1.5 ml and 3 ml media volume, & accommodate multiple tests on the same specimen. They are compatible with culture, immunoassay, and molecular diagnostic techniques. Our Spectra™ MRSA® is a selective chromogenic medium intended for use in the detection of nasal colonization of methicillin-resistant staphylococcus aureus (MRSA). Its easy-to-use, and easy-to-read format enables cost-effective MRSA testing with final results within 24 hours, seven days a week. It can screen more patients, on more shifts in more hospitals.

The company was founded in 1973, has ~20 employees. NYSE:TMO (SEC Filings)

FDA Registration Number: 1031428

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• Gentamicin Enzyme Immunoassay Test (FDA Code: LCD / 862.3450) A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

• Giardia Spp. (FDA Code: MHI / 866.3220)

• Giemsa Stain (FDA Code: HYF / 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.

• Glucose Glucose Dehydrogenase (FDA Code: LFR / 862.1345) A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

• Glucose Hexokinase Test (FDA Code: CFR / 862.1345)

• Glucose Identification Kit (FDA Code: JSW / 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.

• Glucose Tolerance Drink (FDA Code: MRV / 862.1345)

• 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.

• Gold Chloride Stain (FDA Code: HYH / 864.1850)

• Grams Iodine Stain (FDA Code: HYI / 864.1850)

• Haemophilus Influenza Antiserum (FDA Code: GRP / 866.3300)

• Harris's Hematoxylin Stain (FDA Code: HYK / 864.1850)

• Heating Block (FDA Code: JRG / 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.

• Hematocrit Centrifuge (FDA Code: GKG / 864.6400) A hematocrit measuring device is a system consisting of instruments, tubes, racks, and a sealer and a holder. The device is used to measure the packed red cell volume in blood to determine whether the patient's total red cell volume is normal or abnormal. Abnormal states include anemia (an abnormally low total red cell volume) and erythrocytosis (an abnormally high total red cell mass). The packed red cell volume is produced by centrifuging a given volume of blood.

• Hematocrit Control (FDA Code: GLK / 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).

• Hematology Quality Control Mixture (FDA Code: JPK / 864.8625)

• Hematology Stain (FDA Code: KQC / 864.1850)

• Hematoxylin Stain (FDA Code: HYJ / 864.1850)

• 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 Control (FDA Code: GGM / 864.8625)

• Histology Crystal Violet Stain (FDA Code: ICF / 864.1850)

• Home pregnancy test kits, Hcg

• Human/Horse/Rabbit Coagulase Plasma (FDA Code: JTL / 866.2160) Coagulase plasma is a device that consists of freeze-dried animal or human plasma that is intended for medical purposes to perform coagulase tests primarily on staphylococcal bacteria. When reconstituted, the fluid plasma is clotted by the action of the enzyme coagulase which is produced by pathogenic staphylococci. Test results are used primarily as an aid in the diagnosis of disease caused by pathogenic bacteria belonging to the genusStaphylococcus and provide epidemiological information on disease caused by these microorganisms.

• IFA Antibody Antigen Respiratory Syncytial Virus (FDA Code: LKT / 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.

• Immersion Type Slide Stainer (FDA Code: KIO / 864.3800) An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.

• Immunohistochemistry Reagents And Kits (FDA Code: NJT / 864.1860) Immunohistochemistry test systems (IHC's) are in vitro diagnostic devices consisting of polyclonal or monoclonal antibodies labeled with directions for use and performance claims, which may be packaged with ancillary reagents in kits. Their intended use is to identify, by immunological techniques, antigens in tissues or cytologic specimens. Similar devices intended for use with flow cytometry devices are not considered IHC's.

• Incubator/ Water Bath (FDA Code: JTQ / 866.2540) A microbiological incubator is a device with various chambers or water-filled compartments in which controlled environmental conditions, particularly temperature, are maintained. It is intended for medical purposes to cultivate microorganisms and aid in the diagnosis of disease.

• Infectious Disease Identification Test Kits

• Infectious Disease Test Kits

• Infectious Disease Testing Viral Quality Control kits

• 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.

• Influenza Virus (A, B, C) Antisera (FDA Code: GNW / 866.3330) Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic.

• Influenza Virus CF Antigen (FDA Code: GNX / 866.3330)

• Inorganic Phosphorus Phosphomolybdate (FDA Code: CEO / 862.1580) A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

• 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.

• Iron Photometric Method (FDA Code: JIY / 862.1410) An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

• Iron Stain (FDA Code: GGH / 864.1850)

• Isoenzymes Fluorometric Method (FDA Code: JHX / 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.

• Isoenzymes NAD Reduction/NADH Oxidation (FDA Code: CGS / 862.1215)

• Isotonic Solution (FDA Code: JCE / 864.4010)

• Jenner Stain (FDA Code: KJX / 864.1850)

• Labeled Medical Laboratory Equipment (FDA Code: LXG / 862.2050)

• Laboratory Disk Dispensers

• Laboratory Freezers (FDA Code: JRM / 862.2050)

• Laboratory Slides

• Laboratory Stains

• Lactate Dehydrogenase NAD Reduction/NADH Oxidation (FDA Code: CFJ / 862.1440) A lactate dehydrogenase test system is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.

• Lactic Acid Enzymatic Method (FDA Code: KHP / 862.1450) A lactic acid test system is a device intended to measure lactic acid in whole blood and plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

• Latex Agglutination Test for Cryptococcus neoformans (FDA Code: GMD / 866.3165)