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The MEDTOX Buprenorphine Test uses immunochromatographic test strips for the rapid, qualitative detection of buprenorphine and its metabolites in human urine. It is intended for prescription use only. The MEDTOX Buprenorphine Test is not for overthe-counter sale. It is not intended for use in point-of-care settings. MEDTOX Buprenorphine detects buprenorphine and its metabolites at the following cutoff concentrations: Buprenorphine (Buprenorphine) BUP 10 ng/mL The MEDTOX Buprenorphine Test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Liquid chromatography/tandem mass spectrometry (LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any test result.

The MEDTOX® Buprenorphine Test is a rapid, single use, one-step qualitative immunochromatographic screening assay for the detection of Buprenorphine and its metabolites in human urine.

The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System consists of the PROFILE®-V MEDTOXScan® Test Devices and the MEDTOXScan® Reader. The PROFILE®-V MEDTOX Scan® Test Devices are one-step immunochromatographic tests for the rapid, qualitative detection of one or more of the following in human urine: Amphetamines, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Methamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, THC (Cannabinoids), and Tricyclic Antidepressants or their metabolites. The PROFILE®-V MEDTOXScan® Test Devices can only be used with the MEDTOXScan® Reader. The MEDTOX Scan® Reader is an instrument used to interpret and report the results of the PROFILE®-V MEDTOXScan® Test Device. PROFILE®-V MEDTOXScan® Test Devices cannot be visually read. The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System is for in vitro diagnostic use and is intended for professional use only. It is not intended for use in point-of-care settings. The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System detects drug classes at the following cutoff concentrations: AMP Amphetamine (d-Amphetamine) 500 ng/mL BAR Barbiturates (Butalbital) 200 ng/mL BUP Buprenorphine (Buprenorphine) 10 ng/mL BZO Benzodiazepines (Nordiazepam) 150 ng/mL COC Cocaine (Benzoylecgonine) 150 ng/mL MAMP Methamphetamine (d-Methamphetamine) 500 ng/mL MTD Methadone (Methadone) 200 ng/mL OPI Opiates (Morphine) 100 ng/mL or 2000 ng/mL OXY Oxycodone (Oxycodone) 100 ng/mL PCP Phencyclidine (Phencyclidine) 25 ng/mL PPX Propoxyphene (Norpropoxyphene) 300 ng/mL THC Cannabinoids (11-nor-9-carboxy-r9-THC) 50 ng/mL TCA Tricyclic Antidepressants (Desipramine) 300 ng/mL Configurations of the PROFILE®-V MEDTOXScan® Test Devices may consist of any combination of the above listed and previously cleared drug. Test Devices will have an opiate cutoff of either 100 ng/mL or 2000 ng/mL. Refer to specific product labeling for the combination of drug tests included on that test device. THE PROFILE®-V MEDTOXScan® DRUGS OF ABUSE TEST SYSTEM PROVIDES ONLY A PRELIMINARY ANALYTICAL TEST RESULT. A MORE SPECIFIC ALTERNATE CHEMICAL METHOD MUST BE USED IN ORDER TO OBTAIN A CONFIRMED ANALYTICAL RESULT. GAS CHROMATOGRAPHY / MASS SPECTROMETRY (GC/MS), HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) OR LIQUID CHROMATOGRAPHY / TANDEM MASS SPECTROMETRY (LC/MS/MS) ARE THE PREFERRED CONFIRMATORY METHODS. CLINICAL CONSIDERATION AND PROFESSIONAL JUDGMENT SHOULD BE APPLIED TO ANY DRUG OF ABUSE TEST RESULT, PARTICULARLY WHEN PRELIMINARY POSITIVE RESULTS ARE OBTAINED. The MEDTOXScan® Reader includes a Positive QC Test Device, a Negative QC Test Device and a Cleaning Cassette. The MEDTOXScan ® Positive and Negative QC Test Devices are intended to detect errors associated with the MEDTOXScan® Reader and a contaminated contact imaging sensor (CIS), and to verify that the CIS cleaning procedure using the MEDTOXScan® Cleaning Cassette effectively removed any contamination.

The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System consists of the PROFILE®-V MEDTOXScar® Test Devices and the MEDTOXScam® Reader. The MEDTOX Scan® Reader is an instrument used as an aid in determining the presence of a colored line associated with the PROFILE®-V MEDIOXScan® one-step drugs of abuse qualitative screening immunoassays for the detection of one or more of the following in human urine: Amphetamines, Barbiturates, Benzodiazenines, Buprenorphine, Cocaine, Methamphetamine, Opiates, Oxycodone, Phencyclidine. Propoxyphene, THC (Cannabinoids) and Tricyclic Antidepressants or their metabolites. All analytes were previously cleared for the test system (K091454) except for the buprenorphine and opiates with the 2.000 ng/mL cutoff (OPI 2k). OPI 2K was previously cleared for visual use (K992111). The MEDTOXScan® reader scans the device and utilizes a contact imaging sensor (CIS) to capture relative line intensities. Software algorithms and barcodes are used to identify the type of device to be read. the analyte(s) associated with the device and whether the presence or absence of a line is associated with a negative or positive result. The results of the scans are displayed on the MEDTOXScan® screen or optionally can be printed.

The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System consists of the PROFILE® V MEDTOXScan® Test Devices and the MEDTOXScan® Reader. The PROFILE®-V MEDTOX Scan® Test Devices are one-step immunochromatographic tests for the rapid, qualitative detection of one or more of the following in human urine: Amphetamines, Barbiturates, Benzodiazepines, Cocaine, Methadone, Methamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, THC (Cannabinoids), and Tricyclic Antidepressants or their metabolites. The PROFILE®-V MEDTOXScan® Test Devices can only be used with the MEDTOXScan® Reader. The MEDTOX Scan® Reader is an instrument used to interpret and report the results of the PROFILE®-V MEDTOXScan® Test Device. PROFILE®-V MEDTOXScan® Test Devices cannot be visually read. The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System is for in vitro diagnostic use and is intended for professional use only. It is not intended for use in point-of-care settings. The PROFILE® V MEDTOXScan® Drugs of Abuse Test System detects drug classes at the following cutoff concentrations: AMP Amphetamine (d-Amphetamine) 500 ng/mL BAR Barbiturates (Butalbital) 200 ng/mL BZO Benzodiazepines (Nordiazepam) 150 ng/mL COC Cocaine (Benzoylecgonine) 150 ng/mL MAMP Methamphetamine (d-Methamphetamine) 500 ng/mL MTD Methadone (Methadone) 200 ng/mL OPI Opiates (Morphine) 100 ng/mL OXY Oxycodone (Oxycodone) 100 ng/mL PCP Phencyclidine (Phencyclidine) 25 ng/mL PPX Propoxyphene (Norpropoxyphene) 300 ng/mL THC Cannabinoids (11-nor-9-carboxy-Δ9-THC) 50 ng/mL TCA Tricyclic Antidepressants (Desipramine) 300 ng/mL Configurations of the PROFILE®-V MEDTOXScan® Test Devices may consist of any combination of the above listed and previously cleared drug. Refer to specific product labeling for the combination of drug tests included on that test device. THE PROFILE -V MEDTOXScan® DRUGS OF ABUSE TEST SYSTEM PROVIDES ONLY A PRELIMINARY ANALYTICAL TEST RESULT. A MORE SPECIFIC ALTERNATE CHEMICAL . METHOD MUST BE USED IN ORDER TO OBTAIN A CONFIRMED ANALYTICAL RESULT. GAS CHROMATOGRAPHY / MASS SPECTROMETRY (GC/MS), HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) OR LIQUID CHROMATOGRAPHY / TANDEM MASS SPECTROMETRY (LC/MS/MS) ARE THE PREFERRED CONFIRMATORY METHODS. CLINICAL CONSIDERATION AND PROFESSIONAL JUDGMENT SHOULD BE APPLIED TO ANY DRUG OF ABUSE TEST RESULT, PARTICULARLY WHEN PRELIMINARY POSITIVE RESULTS ARE OBTAINED. The MEDTOXScan® Reader includes a Positive QC Test Device, a Negative QC Test Device and a Cleaning Cassette. The MEDTOXScan® Positive and Negative QC Test Devices are intended to detect errors associated with the MEDTOXScan® Reader and a contaminated contact imaging sensor (CIS), and to verify that the CIS cleaning procedure using the MEDTOXScan® Cleaning Cassette effectively removed any contamination.

The PROFILE® V MEDTOXScan® Drugs of Abuse Test System consists of the PROFILE® V MEDTOXScan® Test Devices and the MEDTOXScan® Reader. The MEDTOXScan® Reader is an instrument used as an aid in determining the presence or absence of a colored line associated with the PROFILE®-V MEDTOXScan® one-step drugs of abuse qualitative screening immunoassays for the detection of one or more of the following in human urine: Amphetamines, Barbiturates, Benzodiazepines, Cocaine, Methamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, THC (Cannabinoids) and Tricyclic Antidepressants or their metabolites. All analytes were previously cleared (K080635) except for the oxycodone, propoxyphene, and tricyclic anti-depressant analytes. The MEDTOXScan® reader scans the device and utilizes a contact imaging sensor (CIS) to capture relative line intensities. Software algorithms and barcodes are used to identify the type of device to be read, the analyte(s) associated with the device and whether the presence or absence of a line is associated with a negative or positive result. The results of the scans are displayed on the MEDTOXScan® screen or optionally can be printed.

The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System consists of the PROFILE®-V MEDTOXScan® Test Devices and the MEDTOXScan® Reader. The PROFILE®-V MEDTOXScan® Test Devices are one-step immunochromatographic tests for the rapid, qualitative detection of one or more of the following in human urine: Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Methadone, Methamphetamine, Opiates, Phencyclidine and THC (Cannabinoids) or their metabolites. The PROFILE®-V MEDTOXScan® Test Devices can only be used with the MEDTOXScan® Reader. The MEDTOXScan® Reader is an instrument used to interpret and report the results of the PROFILE®-V MEDTOXScan® Test Device. The PROFILE®-V MEDTOXScan® Test Devices cannot be visually read. The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System is for in vitro diagnostic use and is intended for professional use only. It is not intended for use in point-of-care settings. The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System detects drug classes at the following cutoff concentrations: AMP Amphetamine (d-Amphetamine) 500 ng/mL BAR Barbiturates (Butalbital) 200 ng/mL BZO Benzodiazepines (Nordiazepam) 150 ng/mL COC Cocaine (Benzoylecgonine) 150 ng/mL MAMP Methamphetamine (d-Methamphetamine) 500 ng/mL MTD Methadone (Methadone) 200 ng/mL OPI Opiates (Morphine) 100 ng/mL PCP Phencyclidine (Phencyclidine) 25 ng/mL THC Cannabinoids (11-nor-9-carboxy-C9-THC) 50 ng/mL Configurations of the PROFILE®-V MEDTOXScan® Test Devices may consist of any combination of the above listed drug analytes. THE PROFILE®-V MEDTOXScan® Drugs of Abuse Test System provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) or liquid chromatography/tandem mass spectrometry (LC/MS/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 obtained. The MEDTOXScan® Reader includes a Positive QC Test Device, a Negative QC Test Device and a Cleaning Cassette. The MEDTOXScan® Positive and Negative OC Test Devices are intended to detect errors associated with the MEDTOXScan® Reader and a contaminated contact imaging sensor (CIS) and to verify that the CIS cleaning procedure using the MEDTOXScan® Cleaning Cassette effectively remaved any contamination.

The PROFILE® V MEDTOXScan® Drugs of Abuse Test System consists of the PROFILE® V MEDTOXScan® Test Devices and the MEDTOXScan® Reader. The MEDTOXScan® Reader is an instrument used as an aid in determining the presence of a colored line associated with the PROFILE®-V MEDTOXScan® one-step drugs of abuse qualitative screening immunoassays for the detection of one or more of the following in human urine: Amphetamine, Benzodiazepines, Cocaine, Methadone, Methamphetamine, Opiates. Barbiturates, Phencyclidine, and THC (Cannabinoids) or their metabolites. The MEDTOXScan® reader scans the device and utilizes a contact imaging sensor (CIS) to capture relative line intensities. Software algorithms and barcodes are used to identify the type of device to be read, the analyte(s) associated with the device and whether the presence or absence of a line is associated with a negative or positive result. The results of the scans are displayed on the MEDTOXScan® screen or optionally can be printed. The PROFILE® V MEDTOXScan® Test Devices cannot be visually read.

The MEDTOX® OXYCODONE Test System uses immunochromatographic test strips for the rapid, qualitative detection of oxycodone in human urine. It is intended for prescription point-of-care use including physician office laboratories and central laboratory settings. It is also intended for workplace settings, criminal justice or forensic settings, and drug rehabilitation centers. MEDTOX® OXYCODONE is not for over-the-counter sale. The test detects oxycodone at concentrations 100 ng/mL and above. THE MEDTOX® OXYCODONE PROVIDES ONLY A PRELIMINARY ANALYTICAL TEST RESULT. A MORE SPECIFIC ALTERNATE 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.

Each test strip contains antibody colloidal gold, a drug conjugate and a control line. A mouse monoclonal antibody specific to oxycodone is mixed with colloidal gold and applied to the sample well pad of the strip. Drug is conjugated to protein and immobilized at the test line. Strips have an anti-mouse immunoglobulin antibody immobilized at the control line. The anti-mouse antibody binds the mouse antibody coated on the colloid gold, When urine is applied to the sample well of the device, the dried antibody-colloidal gold on the sample pad dissolves and the urine wicks up the white test strip carrying the red antibody-colloidal gold with it.

The SURE-SCREEN Drugs of Abuse Test System uses immunochromatographic test strips for the rapid, qualitative detection of one or more of the following: Amphetamines, Benzodiazepines, Cocaine, Methamphetamine, Methadone, Opiates, Phencyclidine and THC (Cannabinoids) in human urine. It is intended for prescription point-of-care use including workplace settings, criminal justice or forensic settings, drug rehabilitation clinics, physician offices and laboratory settings. SURE-SCREEN is not for over-the-counter sale.

The SURE-SCREEN Drugs of Abuse Test System uses immunochromatographic test strips for the rapid, qualitative detection of one or more of the following: Amphetamines, Benzodiazepines, Cocaine, Methamphetamine, Methadone, Opiates, Phencyclidine and THC (Cannabinoids) in human urine.

The 3 Panel TCA/BAR/BZO is a one-step immunochromatographic test for the rapid, qualitative detection of tricyclic antidepressants, barbiturates and benzodiazepines and their metabolites. The test detects the major metabolites of these drugs at the following cutoff concentrations: Tricyclis antidepressants (Desipramine) - 50 ng/ml Barbiturates (Phenobarbital)-200 ng/ml Benzodiazepines (Nordiazepam)-300 ng/mL This product is not for over-the-counter-sale The 3 Panel provides only a preliminary analytical test result. A more specific alternate 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

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Verdict®-II THC/COC/OPI/MAMP-MDMA is a one-step immunochromatographic test for the rapid, qualitative detection of cannabinoids, opiates, cocaine, methamphetamine (MAMP), and 3,4-methylenedioxymethylamphetamine (MDMA) and their metabolites. The test detects the major metabolites of these drugs at the following cutoff concentrations: Cannabinoids (11 nor-9-carboxy-Δ 9 -THC)-50 ng/ml Opiates (morphine)-300 ng/ml Cocaine (benzoylecgonine)-300 ng/mL Methamphetamine (MAMP)-1000 ng/mL 3,4-methylenedioxymethlyamphetamine (MDMA)-1500 ng/mL This product is not for over-the-counter-sale Verdict®-II provides only a preliminary analytical test result. A more specific alternate 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

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Verdict®-II Propoxyphene/Methamphetamine-MDMA is a one-step immunochromatographic test for the rapid, qualitative detection of methamphetamine (MAMP), 3,4-methylenedioxymethylamphetamine (MDMA) and their metabolites; propoxyphene, and its main metabolite norpropoxyphene. The test detects the major metabolites of these drugs at the following cutoff concentrations: Methamphetamine (MAMP)-1000 ng/mL 3,4-methylenedioxymethlyamphetamine (MDMA)-1500 ng/mL Norpropoxyphene (Main metabolite of propoxyphene)-300 ng/mL This product is not for over-the-counter-sale Verdict®-II provides only a preliminary analytical test result. A more specific alternate 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

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VERDICT® II PROPOXYPHENE is a one-step immunochromatographic test for the rapid, qualitative detection of propoxyphene and its metabolite, norpropoxyphene, in human urine. The test detects the major urinary metabolite of propoxyphene (norpropoxyphene) at 300 ng/mL. It is not for over-the-counter sale. VERDICT®-II PROPOXYPHENE PROVIDES ONLY A PRELIMINARY ANALYTICAL TEST RESULT. A MORE SPECIFIC ALTERNATE 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 OBTAINED.

VERDICT®-II PROPOXYPHENE is a one-step immunochromatographic test.