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The CLUNGENE Fentanyl Home Test Cassette is competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentany] in human urine at the cut off concentration of 1.0 ng/mL. This test provides only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS) is the preferred confirmatory method. Evaluate preliminary positive results carefully. For in vitro diagnostic use only. The CLUNGENE Fentanyl Test Cassette is competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl in human urine at the cut off concentration of 1.0 ng/mL. This test provides only a preliminary result. A more specific alternative chemical must be used to obtain a confirmed presumptive positive result. Gas Chromatography-Mass Spectrometry (GC-MS). Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results. For in vitro diagnostic use only.

The CLUNGENE Fentanyl Tests are immunoassays intended for the qualitative detection of fentanyl in human urine. Each CLUNGENE Fentanyl Test device consists of a Test Cassette, a Dropper and a package insert. Each Test Cassette is sealed with sachets of desiccant in an aluminum pouch.

The CLUNGENE HCG Pregnancy Rapid Test Cassette is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy. The CLUNGENE HCG Pregnancy Rapid Test Strip is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy. The CLUNGENE HCG Pregnancy Rapid Test Midstream is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.

Clungene HCG Pregnancy Rapid Test will be sold in three different formats: Cassette, Test Strip, and Midstream. The Test Strip and Midstream format contain a test device sealed in a desiccated aluminum pouch and a package insert. The Cassette format contains one test device, a disposable plastic dropper, and a package insert.

CLUNGENE® Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Opiates, Oxycodone, Secobarbital, Methadone, Buprenorphine, Methylenedioxymethamphetamine, Tricyclic Antidepressants, EDDP and Propoxyphene 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 | | Opiates | Morphine | 2000 ng/mL | | Oxycodone | Oxycodone | 100 ng/mL | | Secobarbital | Secobarbital | 300 ng/mL | | Methadone | Methadone | 300 ng/mL | | Buprenorphine | Buprenorphine | 10 ng/mL | | Methylenedioxymethamphetamine | D,L-Methylenedioxymethamphetamine | 500 ng/mL | | Phencyclidine | Phencyclidine | 25 ng/mL | | Tricyclic Antidepressants | Nortriptyline | 1000 ng/mL | | EDDP | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 ng/mL | | Propoxyphene | d-Propoxyphene | 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 Buprenorphine, Oxazepam, Secobarbital, Nortriptyline, Propoxyphene 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 must be used in order to obtain a confirmed analytical result. GCMS or LC/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, Cocaine, Marijuana, Methamphetamine, Opiates, Oxycodone, Secobarbital, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine, Tricyclic Antidepressants, EDDP and Propoxyphene 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 | | Opiates | Morphine | 2000 ng/mL | | Oxycodone | Oxycodone | 100 ng/mL | | Secobarbital | Secobarbital | 300 ng/mL | | Methadone | Methadone | 300 ng/mL | | Buprenorphine | Buprenorphine | 10 ng/mL | | Methylenedioxymethamphetamine | D,L-Methylenedioxymethamphetamine | 500 ng/mL | | Phencyclidine | Phencyclidine | 25 ng/mL | | Tricyclic Antidepressants | Nortriptyline | 1000 ng/mL | | EDDP | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 ng/mL | | Propoxyphene | d-Propoxyphene | 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 Buprenorphine, Oxazepam, Secobarbital, Nortriptyline, Propoxyphene 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 must be used in order to obtain a confirmed analytical result. GC/MS or LC/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, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine, Tricyclic Antidepressants, EDDP and Propoxyphene (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.

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, Methadone, Buprenorphine, Methylenedioxymethamphetamine and Tricyclic Antidepressants 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 | | Buprenorphine | Buprenorphine | 10 ng/mL | | Methylenedioxymethamphetamine | D,L-Methylenedioxymethamphetamine | 500 ng/mL | | Phencyclidine | Phencyclidine | 25 ng/mL | | Tricyclic Antidepressants | Nortriptyline | 1000 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 Buprenorphine, Oxazepam, Secobarbital, Nortriptyline 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. GCMS or LC/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, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine and Tricyclic Antidepressants 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 | | Buprenorphine | Buprenorphine | 10 ng/mL | | Methylenedioxymethamphetamine | D,L-Methylenedioxymethamphetamine | 500 ng/mL | | Phencyclidine | Phencyclidine | 25 ng/mL | | Tricyclic Antidepressants | Nortriptyline | 1000 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 Buprenorphine, Oxazepam, Secobarbital, Nortriptyline 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. GCMS or LC/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, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine and Tricyclic Antidepressants (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.

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.