Profile: Opus Diagnostics, Inc. manufactures therapeutic drug monitoring devices. We deal with drug specific calibrators, digitoxin enzyme immunoassay tests, tobramycin fluorescence polarization immunoassay tests and valproic acid enzyme immunoassay tests.
The company has revenues of < USD 1 Million.
8 Products/Services (Click for related suppliers)
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| • Carbamazepine Enzyme Immunoassay Test (FDA Code: KLT / 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. |
| • Digitoxin Enzyme Immunoassay Test (FDA Code: LFM / 862.3300) A digitoxin test system is a device intended to measure digitoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy. |
| • Drug Specific Calibrator (FDA Code: DLJ / 862.3200) A clinical toxicology 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. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also 862.2 in this part.) |
| • Drug Specific Control Test (FDA Code: LAS / 862.3280) A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials. |
| • Quinidine Enzyme Immunoassay Test (FDA Code: LBZ / 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. |
| • Theophylline Fluorescence Polarization Immunoassay Test (FDA Code: LGS / 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. |
| • Topiramatee Test System (FDA Code: MSL) |
| • Valproic Acid Enzyme Immunoassay Test (FDA Code: LEG / 862.3645) |