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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• Total Protein Biuret Method (FDA Code: CEK / 862.1635) A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.

• Total Protein Turbidimetric Test (FDA Code: JGQ / 862.1635)

• Total Thyroxine Non-Radiolabeled Enzyme Immunoassay (FDA Code: KLI / 862.1700) A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

• Total Triiodothyronine Radioimmunoassay (FDA Code: CDP / 862.1710) A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.

• Trichinella Spiralis Enzyme Linked Immunoabsorbent Assay (FDA Code: MDT / 866.3850)

• Tricyclic Antidepressant Drugs U.V. Spectrometry (FDA Code: LFH / 862.3910) A tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant drugs in serum. The tricyclic antidepressant drugs include imipramine, desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin. Measurements obtained by this device are used in the diagnosis and treatment of chronic depression to ensure appropriate therapy.

• Triglycerides Colorimetric Method Test (FDA Code: JGY / 862.1705) A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

• Triglycerides Lipase Hydrolysis/Glycerol Kinase Enzyme Test (FDA Code: CDT / 862.1705)

• Triiodothyronine Uptake Radioassay (FDA Code: KHQ / 862.1715) A triiodothyronine uptake test system is a device intended to measure the total amount of binding sites available for binding thyroid hormone on the thyroxine-binding proteins, thyroid-binding globulin, thyroxine-binding prealbumin, and albumin of serum and plasma. The device provides an indirect measurement of thyrkoxine levels in serum and plasma. Measurements of triiodothyronine uptake are used in the diagnosis and treatment of thyroid disorders.

• Troponin Subunit Enzymatic Method (FDA Code: MMI / 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.

• U.V. Spectrometry Test for Theophylline (FDA Code: LCY / 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.

• Ultraviolet Alcohol Dehydrogenase Enzymatic Method (FDA Code: DMT / 862.3040) An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.

• Urea Nitrogen Urease and Glutamic Dehydrogenase Test (FDA Code: CDQ / 862.1770) A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

• Uric Acid, Uricase (FDA Code: CDO / 862.1775) A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

• Urinalysis Controls (FDA Code: JJW / 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.

• Urinary Ketones, Nitroprusside Test (FDA Code: JIN / 862.1435) A ketones (nonquantitative) test system is a device intended to identify ketones in urine and other body fluids. Identification of ketones is used in the diagnosis and treatment of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets and patients with diabetes.

• Urinary Nitrite Colorimetric Test (FDA Code: JMT / 862.1510) A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification is used in the diagnosis and treatment of uninary tract infection of bacterial origin.

• Valproic Acid Enzyme Immunoassay Test (FDA Code: LEG / 862.3645) A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.

• Van Gieson's Stain (FDA Code: IAC / 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.

• Vancomycin Radioimmunoassay (FDA Code: LEH / 862.3950) A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

• Vibrio Cholerae Antiserum (FDA Code: GSQ / 866.3930)

• Vitamin B12 Radioimmunoassay (FDA Code: CDD / 862.1810) A vitamin B12test system is a device intended to measure vitamin B12in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

• Water Purifier (FDA Code: JRS / 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.

• Weigert's Iron Hematoxylin Stain (FDA Code: IAE / 864.1850)

• Wright's Stain (FDA Code: IAF / 864.1850)

• Yeast Identification Kit (FDA Code: JXB / 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.

• Yeast Screening Kit (FDA Code: JXC / 866.2660)