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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• 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.

• Rotary Microtomes (FDA Code: IDO / 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.

• Rotavirus Enzyme Linked Immunoabsorbent Assay (FDA Code: LIQ / 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.

• Rubella Enzyme Linked Immunoabsorbent Assay (FDA Code: LFX / 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).

• Rubella Latex Agglutination Assay (FDA Code: LQN / 866.3510)

• Safranin Stain (FDA Code: HZS / 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.

• Salicylate Colorimetry Test (FDA Code: DKJ / 862.3830) A salicylate test system is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human specimens. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.

• Salmonella Spp Antiserum (FDA Code: GRM / 866.3550)

• Schiff Reagent Stain (FDA Code: HZT / 864.1850)

• Secondary Calibrator (FDA Code: JIT / 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.)

• Selective and Differential Culture Media (FDA Code: JSI / 866.2360) A selective culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate and identify certain pathogenic microorganisms. The device contains one or more components that suppress the growth of certain microorganisms while either promoting or not affecting the growth of other microorganisms. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

• Selective and Non-Differential Culture Media (FDA Code: JSJ / 866.2360)

• Selective Broth Culture Media (FDA Code: JSD / 866.2360)

• Sensitive Pregnancy Tests

• Shaker/Stirrer (FDA Code: JRQ / 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.

• Shigella Spp Antiserum (FDA Code: GNB / 866.3660)

• Sickle Cell Test (FDA Code: GHM / 864.7825) A sickle cell test is a device used to determine the sickle cell hemoglobin content of human blood to detect sickle cell trait or sickle cell diseases.

• Single Biochemical Test Culture Media (FDA Code: JSF / 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.

• Sirolimus Test System (FDA Code: NRP / 862.3840) A sirolimus test system is a device intended to quantitatively determine sirolimus concentrations in whole blood. Measurements are used as an aid in management of transplant patients receiving therapy with sirolimus.

• Slide Culture Chamber (FDA Code: KIY / 864.2240) Cell and tissue culture supplies and equipment are devices that are used to examine, propagate, nourish, or grow cells and tissue cultures. These include such articles as slide culture chambers, perfusion and roller apparatus, cell culture suspension systems, and tissue culture flasks, disks, tubes, and roller bottles.

• Slide Warming Lamp (FDA Code: IEH / 864.3010)

• Slide Warming Table (FDA Code: IEG / 864.3010)

• Sliding Microtomes (FDA Code: KFL / 864.3010)

• Specimen Collection Device (FDA Code: LIO / 866.2900) A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

• Staphylococcus Aureus Screening Kit (FDA Code: JWX / 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.

• Staphylococcus Aureus Somatic Antigen Test (FDA Code: LHT / 866.3700)

• Staphylococcus Colonies Resistant Markers, Genotypic Detection Test System (FDA Code: MYI / 866.1640) An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

• Staphylococcus Spp Fluorescent Antisera (All Types) (FDA Code: GTN / 866.3700)

• Steam Sterilizers (FDA Code: FLE / 880.6880) A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.

• Sterile Specimen Mailer and Storage Container (FDA Code: KDT / 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.

• Streptococcus Pneumoniae Antisera (FDA Code: GWC / 866.3740)

• Streptococcus Spp Antigen (FDA Code: GTY / 866.3740)

• Streptococcus Spp Antiserum (FDA Code: GTZ / 866.3740)

• Susceptibility Test Kits

• Swabs

• Swabs, Absorbing

• Tacrolimus Enzyme Immunoassay (FDA Code: MLM / 862.1678) A tacrolimus test system is a device intended to quantitatively determine tacrolimus concentrations as an aid in the management of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and chromatographic assays for tacrolimus.

• Theophylline Enzyme Immunoassay Test (FDA Code: KLS / 862.3880) A theophylline test system is a device intended to measure theophylline (a drug used for stimulation of the muscles in the cardiovascular, respiratory, and central nervous systems) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.

• Theophylline Fluorescence Polarization Immunoassay Test (FDA Code: LGS / 862.3880)

• Theophylline Fluorescent Immunoassay Test (FDA Code: LER / 862.3880)

• Thyroglobulin (FDA Code: DDC / 866.5870) A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.

• Thyroid Autoantibody Test System (FDA Code: JZO / 866.5870)

• Tissue Cassette (FDA Code: IDZ / 864.3010)

• Tissue Culture Dish (FDA Code: KIZ / 864.2240)

• Tissue Culture Flask (FDA Code: KJA / 864.2240)

• Tissue Culture Roller Bottle (FDA Code: KJC / 864.2240)

• Tissue Culture Tube (FDA Code: KJG / 864.3010)

• Tobramycin Fluorescence Polarization Immunoassay Test (FDA Code: LFW / 862.3900) A tobramycin test system is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.

• Tobramycin Fluorescent Immunoassay Test (FDA Code: LCR / 862.3900)

• Topiramatee Test System (FDA Code: MSL)