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The ToxCup® Drug Screen Cup is an in vitro screening test for the rapid detection of multiple drugs and drug metabolites in human urine at or above the following cutoff concentration: AMP Amphetamine 500 ng/ml BAR Secobarbital 300 ng/ml BUPG Buprenorphine Glucuronide 10 ng/ml BZO Oxazepam 300 ng/ml COC Benzoylecgonine 150 ng/ml MDMA 3,4-methylenedioxymethamphetamine 500 ng/ml MET Methamphetamine 500 ng/ml MTD Methadone 300 ng/ml OPI Morphine 300 ng/ml OXY Oxycodone 100 ng/ml PCP Phencyclidine 25 ng/ml PPX Propoxyphene 300 ng/ml TCA Nortriptyline 1000 ng/ml THC 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid 50 ng/ml These tests provide visual qualitative results and are intended for in vitro diagnostic use only. The ToxCup® Drug Screen Cup is available in single drug analyte cassette dip format and/or double drug analyte cassette dip format. It is intended for prescription point-of-care and overthe-counter consumer use. These tests provide only a preliminary test result and are the first step in a two-step process for detecting drugs of abuse in urine. The second step is confirming the results in a certified laboratory. For a quantitative result or to confirm preliminary positive results obtained by the ToxCup® Drug Screen Cup, a more specific alternative method such as Gas Chromatography/Mass Spectrometry (GC/MS) must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when a preliminary positive result is indicated.

The ToxCup® Drug Screen Cup is based on the principle of highly specific immunochemical reactions between antigens and antibodies. It utilizes a competitive immunoassay procedure in which an immobilized drug conjugate competes with the drug present in urine for limited antibody binding sites. The ToxCup® Drug Screen Cup device consists of individual test strips, in single drug analyte cassette dip format and/or double analyte cassette dip format, assembled into separate chambers of a plastic insert and can detect up to 14 drugs in human urine at various cutoff concentrations. The presence of a color band at a specific test region indicates a negative result for that particular test. The absence of a color band at a specific test region indicates presumptive positive result for that particular test. A control band at the control region should always appear regardless of the presence of the drug or its metabolites. The presence of the control band during testing serves as a built in control which indicates that the test has completed and is valid.

The Fastect® II PPX Drug Screen Dipstick Test is a lateral flow immunoassay for the rapid detection of propoxyphene in human urine at or above 300 ng/mL. The Fastect® II Drug Screen Dipstick and QuickTox® Drug Screen Dipcard are lateral flow immunoassay for the rapid detection of multiple drugs and drug metabolites in human urine at or above the following cutoff concentration: THC 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid 50 ng/ml COC Benzoylecgonine 300 ng/ml OPI Morphine 300 ng/ml MET Methamphetamine 500 ng/ml AMP Amphetamine 1000 ng/ml PCP Phencyclidine 25 ng/ml BZO Oxazepam 300 ng/ml BAR Secobarbital 300 ng/ml MTD Methadone 300 ng/ml TCA Nortriptyline 1000 ng/ml MDMA 3,4-methylenedioxymethamphetamine 500 ng/ml OXY Oxycodone 100 ng/ml BUP Buprenorphine 10 ng/ml PPX Propoxyphene 300 ng/ml These tests provide visual qualitative results and are intended for in vitro diagnostic use only. It is for prescription point-of-care use only and not intended for over-the-counter sale to non-professionals. These tests provide only a preliminary test result. For a quantitative result or to confirm preliminary positive results obtained by the QuickTox® Drug Screen Dipcard, Fasted® II Drug Screen Dipstick or Fasted® II PPX Drug Screen Dipstick tests, a more specific alternative method such as Gas Chromatography/Mass Spectrometry (GC/MS) must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test results, particularly when a preliminary positive result is indicated.

The Fastect® II Drug Screen Dipstick with Propoxyphene and QuickTox® Drug Screen Dipcard with Propoxyphene contain multiple drugs and drug metabolites in addition to Propoxyphene. Propoxyphene is added as a new analyte. The Fastect® II PPX Drug Screen Dipstick only contains the propoxyphene analyte. All dipstick and dipcard devices are based on the principle of highly specific immunochemical reactions between antigens and antibodies and all devices utilize a competitive immunoassay procedure in which an immobilized drug conjugate competes with the drug present in urine for limited antibody binding sites. The Fastect® II PPX Drug Screen Dipstick, Fastect® II Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices are standardized to detect Propoxyphene in human urine at a cutoff concentration of 300 ng/ml. These tests can be performed without the use of any additional instruments. A control band with a different antigen/antibody reaction is added to the immunochromatographic membrane strip and should always appear regardless of the presence of drug or metabolite. The appearance of the control band during testing indicates that the test has completed and the test is valid.

The Monitect® MDMA Drug Screen Cassette Test and the Fastect™ II Drug Screen Dipstick Test are in vitro screen tests that contains chromatographic immunoassays for the rapid detection of 3,4-Methylenedioxymethamphetamine (MDMA) in human urine above the cutoff concentration of 500 ng/mL. Both the Monitect® and Fastect™ II devices provide visual, qualitative results only. The devices are intended for in vitro diagnostic use in professional and laboratory settings only. The devices are not intended for over-the-counter sale to lay persons.

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The ToxCup™ Drug Screen Cup is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of amphetamines, cocaine (benzoylecgonine), methamphetamines, opiates, phencyclidine and THC in human urine at the following cutoff concentrations: AMP d-Amphetamine 1000 ng/ml COC Benzoylecgonine 300 ng/ml MET500 d-Methamphetamine 500 ng/ml OPI2000 Morphine 2000 ng/ml OPI300* Morphine 300 ng/ml PCP Phencyclidine 25 ng/ml THC 11-nor-Delta^9 -Tetrahydrocannabinol-9-carboxylic acid 50 ng/ml *The Opiates test is offered at the SAMHSA mandated cut-off concentration of 2000 ng/ml and the optional cu-off concentration indicated. The ToxCup™ Drug Screen Cup provides visual, qualitative results for multiple drugs-ofabused in human urine. The device is intended for professional in vitro diagnostic use only. It is not intended for over-the-counter sale to lay persons.

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The Monitect® Oxycodone Drug Screen Cassette Test and Fastect™ Oxycodone Drug Screen Dipstick Test are in vitro screening test devices for the rapid detection of Oxycodone in human urine. The tests are standardized to detect Oxycodone at a cut-off concentration of 100 ng/mL. The Monitect® Oxycodone Drug Screen Cassette Test and Fastect™ Oxycodone Drug Screen Dipstick Test are used to obtain visual, qualitative results. The assays provide only preliminary results. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmatory method. The devices are intended for professional in vitro diagnostic use only. They are not intended for over-the-counter sale to lay users.

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The QuickTox™ Multiple Drug Dipcard is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of cocaine (benzoylecgonine). morphine, methamphetamine, THC, amphetamines, phencyclidine, benzodiazepine (oxazepam), barbiturate (secobarbital), methadone, nortriptyline and their metabolites in human urine. The cutoff concentrations are as follow: | COC | Benzoylecgonine | 300 ng/ml | |---------|------------------------------------------------------------|------------| | MOR2000 | Morphine 2000 | 2000 ng/ml | | MOR300 | Morphine 300 | 300 ng/ml | | MET1000 | Methamphetamine 1000 | 1000 ng/ml | | MET500 | Methamphetamine 500 | 500 ng/ml | | THC | 11-nor- Delta 9 -Tetrahydrocannabinol-9-carboxylic acid | 50 ng/ml | | AMP | Amphetamine | 1000 ng/ml | | PCP | Phencyclidine | 25 ng/ml | | BZO | Oxazepam | 300 ng/ml | | BAR | Secobarbital | 300 ng/ml | | MTD | Methadone | 300 ng/ml | | TCA | Nortriptyline | 1000 ng/ml | The QuickTox™ Multiple Drug Dipcard is used to obtain visual, qualitative results for multiple drugs-of-abused in humane urine. The device is intended for professional in vitro diagnostic use only. It is not intended for over-the-counter sale to lay persons.

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The QuickTox™ Multiple Drug Dipcard is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of cocaine (benzoylecgonine), morphine, methamphetamine, THC, amphetamines, phencyclidine, benzodiazepine (oxazepam), barbiturate (secobarbital), methadone, nortriptyline and their metabolites in human urine. The cutoff concentrations are as follow: | COC | Benzoylecgonine | 300 ng/ml | |-----|--------------------------------------------------------------|------------| | MOR | Morphine | 2000 ng/ml | | MET | Methamphetamine | 1000 ng/ml | | THC | 11-nor- $$\Delta^9$$ -Tetrahydrocannabinol-9-carboxylic acid | 50 ng/ml | | AMP | Amphetamine | 1000 ng/ml | | PCP | Phencyclidine | 25 ng/ml | | BZO | Oxazepam | 300 ng/ml | | BAR | Secobarbital | 300 ng/ml | | MTD | Methadone | 300 ng/ml | | TCA | Nortriptyline | 1000 ng/ml | The QuickTox™ Multiple Drug Dipcard is used to obtain visual, qualitative results for multiple drugs-of-abused in humane urine. The device is intended for professional in vitro diagnostic use only. It is not intended for over-the-counter sale to lay persons.

The QuickTox™ Multiple Drug Dipcard is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of cocaine (benzoylecgonine), morphine, methamphetamine, THC, amphetamines, phencyclidine, benzodiazepine (oxazepam), barbiturate (secobarbital), methadone, nortriptyline and their metabolites in human urine.

The Scooper™ Drug/Adulterant Test Cup is an in vitro screen test for the rapid detection. The west The Scooper -- Drug/Adulterail: Test Sup Sup son and phencyclidine in human urine. The cutoff concentrations are as follows: | OPI | Morphine | 2000 ng/m | |-----|--------------------------------------------------|-----------| | AMP | Amphetamines | 1000 ng/m | | THC | 11-nor-A9-Tetrahydrocannabinol-9-carboxylic acid | 50 ng/m | | COC | Benzoylecgonine | 300 ng/m | | PCP | Phencyclidine | 25 ng/m | The Scooper™ Drug/Adulteration Test Cup is used to obtain visual, qualitative results The Scooper - Drug/Additeration 2001 Super-the-counter sale to lay persons.

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The Branan Medical Corporation Fastix Drug Screen THC/COC Dipstick Test is an in vitro screen test for the rapid detection of 11-nor-Delta9-Tetrahydrocannabinol-9-carboxylic acid (a metabolite) and Benzoylecgonine in human urine. The cutoff concentrations are as follows: THC 50 ng/ml, COC 300 ng/ml. The test kit is used to obtain a visual, qualitative result and is intended for professional use only. It is not intended for over-the-counter sale to lay persons. The Branan Medical Corporation Fastix Drug Screen THC/COC/MET Dipstick Test is an in vitro screen test for the rapid detection of 11-nor-Delta9-Tetrahydrocannabinol-9-carboxylic acid, Benzoylecgonine and D-Methamphetamine in human urine. The cutoff concentrations are as follows: THC 50 ng/ml, COC 300 ng/ml, MET 1000 ng/ml. The test kit is used to obtain a visual, qualitative result and is intended for professional use only. It is not intended for over-the-counter sale to lay persons. The Branan Medical Corporation Fastix Drug Screen OPI/MET/THC/COC Dipstick Test is an in vitro screen test for the rapid detection of Opiate, Methamphetamine, THC, and Cocaine in human urine. The cutoff concentrations are as follows: OPI 2000 ng/ml, MET 1000 ng/ml, THC 50 ng/ml, COC 300 ng/ml. The test kit is used to obtain a visual, qualitative result and is intended for professional use only. It is not intended for over-the-counter sale to lay persons. The Branan Medical Corporation Fastix Drug Screen OPI/AMP/THC/COC Dipstick Test is an in vitro screen test for the rapid detection of Opiate, Amphetamine, THC and Cocaine in human urine. The cutoff concentrations are as follows: OPI 2000 ng/ml, AMP 1000 ng/ml, THC 50 ng/ml, COC 300 ng/ml. The test kit is used to obtain a visual, qualitative result and is intended for professional use only. It is not intended for over-the-counter sale to lay persons.

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