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CLUNGENE® Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Ampletamine, Oxazepam, Methamphetamine, Morphine, Oxycodone, Secobarbital and Methadone in human urine at the cutoff concentrations of: | Drug(Identifier) | Calibrator | Cut-off level | |------------------|---------------------------------------|---------------| | Amphetamine | d-Amphetamine | 1000 ng/mL | | Oxazepam | Oxazepam | 300 ng/mL | | Cocaine | Benzoylecgonine | 300 ng/mL | | Marijuana | 11-Nor-△9-Tetrahydrocannabinol-9-COOH | 50 ng/mL | | Methamphetamine | d-Methamphetamine | 1000 ng/mL | | Morphine | Morphine | 300 ng/mL | | Oxycodone | Oxycodone | 100 ng/mL | | Secobarbital | Secobarbital | 300 ng/mL | | Methadone | Methadone | 300 ng/mL | Configuration of the CLUNGENE® Multi-Drug Test Dip Card can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Oxazepam. Secobarbital and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. For in vitro diagnostic use only. CLUNGENE® Multi-Drug Test Easy Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone. Secobarbital and Methadone in human urine at the cutoff concentrations of: | Drug(Identifier) | Calibrator | Cut-off level | |------------------|---------------------------------------|---------------| | Amphetamine | d-Amphetamine | 1000 ng/mL | | Oxazepam | Oxazepam | 300 ng/mL | | Cocaine | Benzoylecgonine | 300 ng/mL | | Marijuana | 11-Nor-△9-Tetrahydrocannabinol-9-COOH | 50 ng/mL | | Methamphetamine | d-Methamphetamine | 1000 ng/mL | | Morphine | Morphine | 300 ng/mL | | Oxycodone | Oxycodone | 100 ng/mL | | Secobarbital | Secobarbital | 300 ng/mL | | Methadone | Methadone | 300 ng/mL | Configuration of the CLUNGENE® Multi-Drug Test Easy Cup can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Oxazepam. Secobarbital and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

The CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital and Methadone (target analytes) in human urine. The products are single-use in vitro diagnostic devices. The CLUNGENE Multi-Drug Test Dip Card kit contains a Dip Card device, a package insert and a urine cup for sample collection. The CLUNGENE Multi-Drug Test Easy Cup kit contains a Cup device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.