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Healgen Propoxyphene Test is an immunochromatographic assay for the qualitative determination of Propoxyphene in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Dip Card format and a Cup format. The test may yield preliminary positive results even when the prescription drug Propoxyphene is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Propoxyphene in urine. 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 prefered confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use. Healgen Nortriptyline Test is an immunochromatographic assay for the qualitative determination of Nortriptyline in human urine at a Cut-Off concentration of 1000 ng/mL. The test is available in a Strip format, a Dip Card format and a Cup format. The test may yield preliminary positive results even when the prescription is ingested, at prescribed doses, it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Nortriptyline in urine. 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 prefered confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use. Healgen EDDP (Methadone Metabolite) Test is an immunochromatographic assay for the qualitative determination of EDDP (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine) in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format. 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. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use.

Healgen Propoxyphene Test, Healgen Nortriptyline Test and Healgen EDDP (Methadone Metabolite) Test are immunochromatographic assays for Propoxyphene, Nortriptyline and EDDP. Each assay test is a lateral flow system for the qualitative detection of Propoxyphene, Nortriptyline and EDDP (target analyte) in human urine. The products are in vitro diagnostic devices, which come in the form of: Strips, Cassettes, DipCards, or Cups. Each product contains a Test Device (in one of the four formats), and a package insert. Each test device is sealed with a desiccant in an aluminum pouch.

CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine is a rapid test for the qualitative detection of Nortriptyline (a major metabolite of Tricyclic Antidepressants) and Buprenorphine in human urine at a cutoff concentration of 1000ng/mL and 10ng/mL, respectively. The test is the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained. The test is intended for over-the-counter and for prescription use. The test may yield preliminary positive results even when prescription drugs including Tricyclic Antidepressants and Buprenorphine are ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of these drugs. There are no uniformly recognized cutoff concentration levels for Nortriptyline in urine. 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. Clinical consideration and professional iudgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only.

The CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine test uses immunochromatographic assays for nortriptyline and buprenorphine. The test is a lateral flow, one step system for the qualitative detection of nortriptyline and buprenorphine in human urine.

Wondfo Phencyclidine Urine Test and Wondfo Phencyclidine Urine are intended for the qualitative determination of Phencyclidine and Notriptyline (target analytes)at the specific cut-off concentration in human urine. They are intended for healthcare professional use and over the counter use. Wondfo Phencyclidine Urine Test is an immunochromatographic assay for the qualitative determination of Phencyclidine in human urine at a cutoff concentration of 25ng/mL. The test is available in a dip card format and a cup format. It is intended for prescription use and over the counter use. Wondfo Notriptyline Urine Test is an immunochromatographic assay for the qualitative determination of Notriptyline (major metabolite of Tricyclic Antidepressants) in human urine at a cutoff concentration of 1000 ng/mL. The test is available in a dip card format. It is intended for prescription use and over the counter use.

Immunochromatograph assay for Phencyclidine and Notriptyline Urine Test using a lateral flow, one step system for the qualitative detection of Phencyclidine and Notriptyline (target analytes) in human urine. Each assay uses a monoclonal antibody-dye conjugate from mouse against drug with gold chloride and fixed drug-protein conjugate and anti-mouse IgG polyclonal antibody in membrane.

The UCP Multiple Drug Screen Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of Amphetamine, Barbiturates, Bezodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiate 2000, Oxycodone, Phencyclidine, Tricyclic Antidepressants, Propoxyphene and their metabolites in human urine at the following cutoff levels: | Test | Calibrator | Cut-off | |--------------------------|-------------------|------------| | Amphetamine | D-Amphetamine | 1000 ng/mL | | Barbiturates | Secobarbital | 300 ng/mL | | Benzodiazepines | Oxazepam | 300 ng/mL | | Cocaine | Benzoylecgonine | 300 ng/mL | | Marijuana | Delta-9-THC-COOH | 50 ng/mL | | Methadone | Methadone | 300 ng/mL | | Methamphetamine | D-Methamphetamine | 1000 ng/mL | | MDMA | MDMA | 500 ng/mL | | Morphine | Morphine | 300 ng/mL | | Opiate 2000 | Morphine | 2000 ng/mL | | Oxycodone | Oxycodone | 100 ng/mL | | Phencyclidine | Phencylidine | 25 ng/mL | | Tricyclic Antidepressant | Nortriptyline | 1000 ng/mL | | Propoxyphene | Propoxyphene | 300 ng/mL | The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). The test configuration comes with any combination of multiple drug screen tests. Clinical considerations and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels. Prescription Use (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C)

The UCP Multiple Drug Screen Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of Amphetamine, Barbiturates, Bezodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiate 2000, Oxycodone, Phencyclidine, Tricyclic Antidepressants, Propoxyphene and their metabolites in human urine.

The UCP Rapid TM Drug Screening Tricyclic Antidepressant Test and UCP Rapid™ Drug Screening Propoxyphene Test are rapid, qualitative, competitive binding immunoassays for the detection of Tricyclic Antidepressants, Propoxyphene and their metabolites in human urine at the following cutoff levels: Test | Calibrator | Cut-off ---|---|--- Tricyclic Antidepressant | Nortriptyline | 1000 ng/mL Propoxyphene | Propoxyphene | 300 ng/mL The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). The test configuration comes with either single drug test or in combination with multiple other drug tests. Clinical considerations and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.

UCP Rapid 100 Drug Screening Tricyclic Antidepressant, Propoxyphene Tests are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Tricyclic Antidepressant, Propoxyphene and their metabolites at the cut-off levels as indicated. The tests can be performed without the use of an instrument.

The ACON TCA One Step Tricyclic Antidepressants Test Strip and ACON TCA One Step Tricyclic Antidepressant Test Device are rapid chromatographic immunoassays for the qualitative detection of Tricyclic Antidepressants in human urine at a cut-off concentration of 1,000 ng/mL in reference to Nortriptyline. They are intended for Healthcare professionals including professionals at the point-of-care sites.

The ACON TCA One Step Tricyclic Antidepressant Test Strip and ACON TCA One Step Tricyclic Antidepressant Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Tricyclic Antidepressant in a urine sample. The test is based on the principle of antigen-antibody immuncchemistry. It utilizes mouse monoclonal antibody to selectively detect elevated levels of Tricyclic Antidepressant in urine at a cut-off concentration of 1000 ng/mL for Nortriptyline. These tests can be performed without the use of an instrument. A drug-positive urine specimen will not generate a colored-line in the designated test region, while a negative urine specimen or a urine specimen containing Tricyclic Antidepressant at the concentration below the cut-off level will generate a colored-line in the test region. To serve as a procedural control. a colored-line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

Immunoassay for the qualitative detection of TCA in human urine to assit in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drugs

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