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The Amedica Drug Screen Test THC/COC/OPI/AMP/MET/PCP/MDMA/BAR/BZO/MTD/TCA/OXY is an in vitro diagnostic test for the rapid detection of the following drugs in human urine: THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, OXY. This test is intended for use by over-the-counter (OTC) consumers as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample.

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The Amedica Home Drug Test Cup is an in vitro diagnostic test for the rapid detection of the following drugs in human urine. Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, Opiates300, Pencyclidine, Barbiturates, Benzodiazepines, Methadone, Oxycodone, MDMA, Tricyclic Antidepressants. This test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing the second step in the process, is provided in the package labeling.

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The AmediCheck Drug Screen Test THC/COC/OPVAMP/MET/PCP/BAR/BZQ/MDMA/OXY/MTD/ PPX/TCA is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, amphetamine, methamphetamine, phencyclidine, barbiturates, benzodiazepines, MDMA, oxycodone, methadone, propoxyphene and tricyclic antidepressants in human urine at the following cutoff concentration: THC 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic 50 ng,ml COC Benzoylecgonine 300 ng,ml OPI Morphine 2000 ng,ml OPI Morphine 300 ng,ml AMP Amphetamine 1000 ng,ml MET Methamphetamine 1000 ng,ml PCP Phencyclidine 25 ng,ml MDMA 3,4 methylenedioxymethamphetamine 500 ng/ml BAR Secobarbital 300 ng/ml BZO Oxazepam 300 ng/ml MTD Methadone 300 ng/ml TCA Nortriptyline 1000 ng/ml PPX Propoxyphene 300 ng/ml OXY Oxycodone 300 ng/ml This test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale. This assay provides only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometers (GCMS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

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The Amedica Drug Screen Test Cup II THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, PPX, OXY is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, amphetamine, methamphetamine, phencyclidine, MDMA, barbiturates, benzodiazepines, methadone, tricyclic antidepressants, propoxyphene and oxycodone in human urine at the following cutoff concentration: THC 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic 50 ng,ml COC Benzoylecgonine 300 ng,ml OPI Morphine 2000 ng,ml OPI Morphine 300 ng,ml AMP Amphetamine 1000 ng,ml MET Methamphetamine 1000 ng,ml PCP Phencyclidine 25 ng,ml MDMA 3,4 methylenedioxymethamphetamine 500 ng/ml BAR Secobarbital 300 ng/ml BZO Oxazepam 300 ng/ml MTD Methadone 300 ng/ml TCA Nortriptyline 1000 ng/ml PPX Propoxyphene 300 ng/ml OXY Oxycodone 300 ng/ml This test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale. This assay provides only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

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The Amedica Drug Screen THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, PPX, OXY Test Cup is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, amphetamine, methamphetamine, phencyclidine, barbiturates, benzodiazepines, methadone, tricyclic antidepressants, MDMA. propoxyphene and oxycodone in human urine at the following cutoff concentration: THC: 11-nor-Δ⁹-Tetrahydrocannabinol-9-carboxylic, 50 ng/ml COC: Benzoylecgonine, 300 ng/ml OPI: Morphine, 2000 ng/ml OPI: Morphine, 300 ng/ml AMP: Amphetamine, 1000 ng/ml MET: Methamphetamine, 1000 ng/ml PCP: Phencyclidine, 25 ng/ml MDMA: 3,4 methylenedioxymethamphetamine, 500 ng/ml BAR: Secobarbital, 300 ng/ml BZO: Oxazepam, 300 ng/ml MTD: Methadone, 300 ng/ml TCA: Nortriptyline, 1000 ng/ml PPX: Propoxyphene, 300 ng/ml OXY: Oxycodone, 300 ng/ml This test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale. This assay provides only a preliminary result. A more specific alternative chemical method is needed to obtain a confirmed result. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)

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The Amedica Drug Screen THC/COC, OPI300, PPX, OXY, BAR/BZO Test is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, oxycodone, secobarbital and oxazepam in human urine at the following cut-off concentration | THC | 11-nor-Δ⁹-THC-9-COOH | 50 ng/ml | |-----|----------------------|-----------| | COC | benzoylecgonine | 300 ng/ml | | OPI | morphine | 300 ng/ml | | PPY | propoxyphene | 300 ng/ml | | OXY | oxycodone | 100 ng/ml | | BAR | secobarbital | 300 ng/ml | | BZO | oxazepam | 300 ng/ml | This test kit is used to obtain a visual, qualitative result and is intended for use in laboratories and workplaces by trained users. It is not intended for over the counter sale. For in vitro diagnostic use

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The Amedica Drug Screen MDMA-BAR-BZO-MTD-TCA Test is an in vitro diagnostic test for the rapid detection of 3,4 methylenedioxymethamphetamine, secobarbital, oxazepam, methadone and nortriptyline in human urine at the following cut-off concentration. | MDMA | 3,4 methylenedioxymethamphetamine | 500 ng/ml | |------|-----------------------------------|------------| | BAR | secobarbital | 300 ng/ml | | BZO | oxazepam | 300 ng/ml | | MTD | methadone | 300 ng/ml | | TCA | nortriptyline | 1000 ng/ml | This test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale.

Membrane based one-step, lateral flow, competitive immunoassay use colloidal gold for visual detection of 3,4 methylenedioxymethamphetamine, secobarbital, oxazepam, methadone and nortriptyline.

The Amedica Drug Screen Methamphetamine Test is a immunochromatographic assay for the rapid detection of methamphetamine in human urine at a cutoff concentration of 1000 ng/ml. This assay has not been evaluated at point-of-care locations and is intended for use by healthcare professionals. This assay provides only a preliminary result. A more specific alternative chemical method is needed to obtain a confirmed result.

Membrane based one-step, lateral flow, competitive immunoassay use colloidal gold for visual detection. The test cutoff is 1000 ng/ml.

The Amedica Drug Screen Amphetamine Test is a immunochromatographic assay for the rapid detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/ml. This assay has not been evaluated at point-of-care locations and is intended for use by healthcare professionals. This assay provides only a preliminary result. A more specific alternative chemical method is needed to obtain a confirmed result. The Amedica Drug Screen Amphetamine Test is an in vitro diagnostic test for the rapid detection of amphetamine in human urine at a cutoff of 1000 ng/ml. This test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale. This assay provides only a preliminary result. A more specific alternative chemical method is needed to obtain a confirmed result.

Membrane based one-step, lateral flow, competitive immunoassay use colloidal gold for visual detection. The cutoff is 1000 ng/ml.

The Amedica Drug Screen Phencyclidine Test is an in vitro diagnostic test for the rapid detection of Phencyclidine in human urine at a cutoff of 25 ng/ml. This test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale. This assay provides only a preliminary result. A more specific alternative chemical method is needed to obtain a confirmed result.

Membrane based one-step, lateral flow, competitive immunoassay use colloidal gold for visual detection. The test cutoff is 25 ng/ml.