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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• Nocotine And Nicotine Metabolites Enzyme Immunoassasy (FDA Code: MKU / 862.3220) A carbon monoxide test system is a device intended to measure carbon monoxide or carboxyhemoglobin (carbon monoxide bound to the hemoglobin in the blood) in blood. Measurements obtained by this device are used in the diagnosis and treatment of or confirmation of carbon monoxide poisoning.

• Non-Pneumatic Tourniquet (FDA Code: GAX / 878.5900) A nonpneumatic tourniquet is a device consisting of a strap or tubing intended to be wrapped around a patient's limb and tightened to reduce circulation.

• 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-Selective and Differential Culture Media (FDA Code: JSH / 866.2320) A differential culture medium is a device that consists primarily of liquid biological materials intended for medical purposes to cultivate and identify different types of pathogenic microorganisms. The identification of these microorganisms is accomplished by the addition of a specific biochemical component(s) to the medium. Microorganisms are identified by a visible change (e.g., a color change) in a specific biochemical component(s) which indicates that specific metabolic reactions have occurred. Test results aid in the diagnosis of disease and also provide epidemiological information on diseases caused by these microorganisms.

• Non-Selective and Non-Differential Culture Media (FDA Code: JSG / 866.2300) A multipurpose culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes for the cultivation and identification of several types of pathogenic microorganisms without the need of additional nutritional supplements. Test results aid in the diagnosis of disease and also provide epidemiological information on diseases caused by these microorganisms.

• Non-Sterile Specimen Container (FDA Code: NNI / 864.3250) A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.

• Non-Sterile Temperature Controlled Specimen Mailer And Storage Container (FDA Code: NNL / 864.3250)

• Non-Treponemal Antigen (FDA Code: GMQ / 866.3820)

• Normal And Abnormal Hemoglobin Standards And Controls (FDA Code: GFS / 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).

• Normal Control Plasma (FDA Code: GIZ / 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.

• Nuclear Fast Red Stain (FDA Code: HZF / 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.

• Opiates Enzyme Immunoassay Test (FDA Code: DJG / 862.3650) An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

• Oxalate Test System (FDA Code: LPW / 862.1542) An oxalate test system is a device intended to measure the concentration of oxalate in urine. Measurements of oxalate are used to aid in the diagnosis or treatment of urinary stones or certain other metabolic disorders.

• Papanicolau Stain (FDA Code: HZJ / 864.1850)

• Paraffin Dispenser (FDA Code: IDW / 864.3010) Tissue processing equipment consists of devices used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.

• Paraffin Melting Point Apparatus (FDA Code: IDT / 864.3010)

• Parainfluenza Virus CF Antigen (FDA Code: GQS / 866.3400) Parainfluenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to parainfluenza virus in serum. The identification aids in the diagnosis of parainfluenza virus infections and provides epidemiological information on diseases caused by these viruses. Parainfluenza viruses cause a variety of respiratory illnesses ranging from the common cold to pneumonia.

• Pathogenic Neisseria Culture Media (FDA Code: JTY / 866.2410) A culture medium for pathogenicNeisseria spp. is a device that consists primarily of liquid or solid biological materials used to cultivate and identify pathogenicNeisseria spp. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusNeisseria, such as epidemic cerebrospinal meningitis, other meningococcal disease, and gonorrhea, and also provides epidemiological information on these microorganisms.

• Pathology Tissue Flotation Bath (FDA Code: IDY / 864.3010)

• Periodic Acid (FDA Code: KKS / 864.1850)

• pH Buffer (FDA Code: JCC / 864.4010)

• Phencyclidine Enzyme Immunoassay (FDA Code: LCM)

• Phenobarbital Enzyme Immunoassay Test (FDA Code: DLZ / 862.3660) A phenobarbitol test system is a device intended to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.

• Phenobarbital Fluorescence Polarization Immunoassay Test (FDA Code: LGQ / 862.3660)

• Phenobarbital Nephelometric Inhibition Immunoassay Test (FDA Code: LFN / 862.3660)

• Physical/Chemical Sterilization Process Indicator (FDA Code: JOJ / 880.2800) A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.

• Phytohemaglutinin M (FDA Code: IBB / 864.4010)

• 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)

• Poliovirus 1-3 Fluorescent Antisera Test (FDA Code: GOE / 866.3405) Poliovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to poliovirus in serum. Additionally, some of these reagents consist of poliovirus antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify polioviruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of poliomyelitis (polio) and provides epidemiological information on this disease. Poliomyelitis is an acute infectious disease which in its serious form affects the central nervous system resulting in atrophy (wasting away) of groups of muscles, ending in contraction and permanent deformity.

• Polyethylene Glycol Preservative (FDA Code: IFL / 864.4010)

• Positive and Negative Febrile Antigen Control Serum (FDA Code: GSN / 866.3085)

• Pregnancy Kits

• Pregnancy Testing Kits

• Prepared Culture Media

• Preps & Swabs

• Primary Calibrator (FDA Code: JIS / 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.)

• Procainamide Enzyme Immunoassay Test (FDA Code: LAR / 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.

• Progesterone Receptor Antibody Immunohistochemistry Assay (FDA Code: MXZ / 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.

• Propagating Transport Culture Media (FDA Code: JSN / 866.2390)

• Propoxyphene Enzyme Immunoassay (FDA Code: JXN / 862.3700) A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.

• Proteus Spp Fluorescent Antisera (FDA Code: GSY / 866.3410)

• Prothrombin Time Test (FDA Code: GJS / 864.7750) A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).

• Quality Control Kits (FDA Code: JTR / 866.2480) A quality control kit for culture media is a device that consists of paper discs (or other suitable materials), each impregnated with a specified, freeze-dried, viable microorganism, intended for medical purposes to determine if a given culture medium is able to support the growth of that microorganism. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

• Quality Control Slide (FDA Code: LJG / 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.

• Quinidine Enzyme Immunoassay Test (FDA Code: LBZ / 862.3320)

• Radial Immunodiffusion Plates and Equipment (FDA Code: JZQ / 866.4800) A radial immunodiffusion plate for clinical use is a device that consists of a plastic plate to which agar gel containing antiserum is added. In radial immunodiffusion, antigens migrate through gel which originally contains specific antibodies. As the reagents come in contact with each other, they combine to form a precipitate that is trapped in the gel matrix and immobilized.

• Refrigerated Centrifuges (FDA Code: JQC / 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.

• Respiratory Syncytial CF Antigen (FDA Code: GQG / 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.

• Reticulocyte Stain (FDA Code: GJH / 864.1850)