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The LYHER® Oral fluid Multi-Drug Test Kit (Cube) is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and Delta-9-Tetrahydrocanabinol in human oral fluid. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: | Test | Calibrator | Cut-off (ng/mL) | |-----------------------|------------------------------|-----------------| | Opiates(OPI) | Morphine | 40 | | Cocaine (COC) | Benzoylecgonine | 20 | | Amphetamine (AMP) | d-Amphetamine | 50 | | Marijuana (THC) | Delta-9-Tetrahydrocannabinol | 40 | | Methamphetamine (MET) | d-Methamphetamine | 50 | | Phencyclidine (PCP) | Phencyclidine | 10 | The single or multi-test panels can consist of the above insted analytes in anycombination, up to a maximum of 6 analytes. The tests provide only a preliminary result. A more specific alternate chemical must be used in order to obtain a confirmed analytical test 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.

The LYHER® Oral fluid Multi-Drug Test Kit (Cube) is an immunochromatographic assay that uses a lateral flow system for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and Delta-9-Tetrahydrocannabinol in human oral fluid. The LYHER® Oral fluid Multi-Drug Test Kit (Cube) device consists of a cube device, an oral fluid collection swab and a package insert.

BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine. Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in human urine. The test cutoff concentrations and the compounds the tests are calibrated to are as follows: | Test | Calibrators | Cut-off Level | |-----------------------|-------------------|---------------| | Amphetamine (AMP) | d-Amphetamine | 1000ng/ml | | Oxazepam | Oxazepam | 300ng/ml | | Cocaine (COC) | Benzoylecgonine | 300ng/ml | | Methamphetamine (MET) | d-Methamphetamine | 1000ng/ml | | Morphine(MOP) | Morphine | 300ng/ml | | Marijuana (THC) | Delta-9-THC-COOH | 50ng/ml | The cassette test may be configured as single drug test in any drug analytes listed in the table. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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. The test is intended for over the counter use. BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: | Test | Calibrators | Cut-off Level | |-----------------------|-------------------|---------------| | Amphetamine (AMP) | d-Amphetamine | 1000ng/ml | | Oxazepam | Oxazepam | 300ng/ml | | Cocaine (COC) | Benzoylecgonine | 300ng/ml | | Methamphetamine (MET) | d-Methamphetamine | 1000ng/ml | | Morphine(MOP) | Morphine | 300ng/ml | | Marijuana (THC) | Delta-9-THC-COOH | 50ng/ml | The cassette test may be configured as single drug test in any drug analytes listed in the table. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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. The test is intended for prescription use.

The BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use are immunochromatographic assays that use a lateral flow system for the qualitative detection of of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH (target analytes) in human urine. The tests are 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 OralTox® Oral Fluid Drug Test is a competitive binding, lateral flow immunochromatographic assay for the qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana (THC), Methamphetamine, Opiates, Phencyclidine, Oxycodone and Methadone in human oral fluid at the cutoff concentrations listed below and their metabolites: | Test | Calibrator | Cutoff (ng/mL) | |-----------------------|------------------------------|----------------| | Amphetamine (AMP) | d-Amphetamine | 50 | | Cocaine (COC) | Benzoylecgonine | 20 | | Marijuana (THC) | Delta-9-Tetrahydrocannabinol | 40 | | Methamphetamine (MET) | d-Methamphetamine | 50 | | Opiates (OPI) | Morphine | 40 | | Phencyclidine (PCP) | Phencyclidine | 10 | | Oxycodone (OXY) | Oxycodone | 20 | | Methadone (MTD) | Methadone | 30 | The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Liquid Chromatography/Mass Spectrometry/ Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. It is not intended to detect intermittent dosing of Oxycodone. Clinical consideration and professional judgment should be exercised with any drug of abuse test result. particularly when the preliminary result is positive.

The OralTox Oral fluid Drug Test is an immunochromatographic assay that uses a lateral flow system for the qualitative detection of Amphetamine, Cocaine, Cannabinoids, Methamphetamine, Morphine, Phencyclidine. Oxycodone and Methadone (target analytes) in human oral fluid. The products are single-use in vitro diagnostic devices. Each test kit contains a test cup, a package insert and a sample collection sponge. Each test device is sealed with a desiccant in an aluminum pouch.

The Oral Fluid Drug Test is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana (THC), Methamphetamine, Opiates and Phencyclidine, in human oral fluid at the cutoff concentrations listed below and their metabolites: | Test | Calibrator | Cutoff (ng/mL) | |-----------------------|------------------------------|----------------| | Amphetamine (AMP) | d-Amphetamine | 50 | | Cocaine (COC) | Benzoylecgonine | 20 | | Marijuana (THC) | Delta-9 Tetrahydrocannabinol | 40 | | Methamphetamine (MET) | d-Methamphetamine | 40 | | Opiates (OPI) | Morphine | 40 | | Phencyclidine (PCP) | Phencyclidine | 10 | The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Liquid Chromatography/Mass Spectrometry (LC/MS/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.

The OralTox Oral fluid Drug Test is immunochromatographic assay that uses a lateral flow system for the qualitative detection of Amphetamine, Cocaine, Cannabinoids, Methamphetamine, Opiates and Phencyclidine (target analytes) in human oral fluid. The tests are 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.

AssureTech Marijuana Tests are immunochromatographic assays for the qualitative determination of 11-Nor-△9-Tetrahydrocannabinol-9-COOH in human urine at cut-off concentration of 50 ng/mL. The tests are available in a Strip format, a Cup format, a Dip Card format and a Turn Key Split Cup format. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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. The tests are intended for over-the-counter and for prescription use. AssureTech Methamphetamine Tests are immunochromatographic assays for the qualitative determination of d-Methamphetamine in human urine at cut-off concentration of 1000 ng/mL. The tests are available in a Strip format, a Cup format, a Dip Card format and a Turn Key Split Cup format. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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. The tests are intended for over-the-counter and for prescription use. AssureTech Phencyclidine Tests are immunochromatographic assays for the qualitative determination of Phencyclidine in human urine at cut-off concentration of 25 ng/mL. The tests are available in a Strip format, a Dip Card format and a Turn Key Split Cup format. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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. The tests are intended for over-the-counter and for prescription use.

The AssureTech Methamphetamine Tests, AssureTech Phencyclidine Tests, and AssureTech Marijuana Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Methamphetamine, Phencyclidine and Marijuana (target analytes) in human urine. The tests are 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.

Wondfo Methamphetamine Urine Test (MET 300) is an immunochromatographic assay for the qualitative determination of D(+)-Methamphetamine in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care use. 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. Wondfo Oxazepam Urine Test (BZO 200) is an immunochromatographic assay for the qualitative determination of Oxazepam in human urine at a Cut-Off concentration of 200 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care use. 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.

Immunochromatographic assays for Methamphetamine and Oxazepam Urine Tests use a lateral flow, one step system for the qualitative detection of D(+)-Methamphetamine and Oxazepam (target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate against drugs with gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in membranes. Oxazepam is part of the Benzodiazepine class of drugs of abuse.

TUBI's UNISCAN-DoA is a system intended for use in Drugs of Abuse Screening Tests. This mAMP/Opi/THC panel test is a prescription assay intended for use with UNISCAN-DoA scanner in laboratory by professional personnel. The mAMP/Opi/THC assays were calibrated with d-methamphetamine/morphine/11-nor-△-THC-9-COOH, respectively. It provides qualitative screening results for Methamphetamine/ Opiate/cannabinoids in human urine at a cutoff concentration of 1000/300/50 ng/ml. For In Vitro Diagnostic Use. This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any Drug of Abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the recommended confirmatory method.

The UNISCAN-DoA system includes UNISCAN-DoA scanner and mAMP/Opi/THC panel test. The UNISCAN-DoA scanner is a scientific measurement device for color intensity of developed test strip. The color intensity of a test line is detected by the contact image sensor (CIS) inside the device. The test strip of UNISCAN-DoA system is a one-step, colloidal gold based chromatographic immunoassay for the rapid, qualitative detection of Methamphetamine, Opiates, and THC (Cannabinoid). The device contains a membrane strip, which is pre-coated with drug-protein conjugate at the test region of the membrane strip. A wicking pad containing anti-drug monoclonal antibody-conjugate is placed at one end of the membrane. The device contains a control region which has a different antigen/antibody from the test region. The assay relies on the competition for binding antibody between drug conjugate and free drug that may be present in the urine specimen being tested. When drug is present in the urine specimen, it competes with drug conjugate for limited amount of antibody-colloidal gold conjugate. If the drug is present in the urine specimen, it will prevent the binding of drug conjugate to the antibody. Therefore, the color intensity of the test line is reduced. The higher the drug concentration is present in the urine specimen, the lower the color intensity is in the test line of a strip. The color intensity of a test line is inversely proportional to the drug concentration in the urine specimen. The correlation between the color intensity and the drug concentration is described by a calibration curve, whose coefficients are determined via nonlinear regression based on the experimental data. The calibration curve equation and its coefficients are stored in UNISCAN-DoA scanner. Once a developed test strip is inserted into the scanner and is scanned by the device, the color intensity of a test line is detected by the contact image sensor (CIS) inside the device and the signal is converted to drug concentration according to the stored calibration curve equation and its coefficients. The qualitative result is then displayed on the LCD screen of the device. A control line is present at the control region to work as procedural control. This colored band should always appear at the control region regardless the presence of drugs or metabolite. The UNISCAN-DoA scanner automatically detects the color intensity of a control line. If the control line of an inserted test strip does not be detected by the device, "Strip is Failed!" will be displayed on the LCD screen of the device.

Acro Rapid MDMA Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of MDMA in human urine at a cutoff of 500 ng/mL. The test is used to obtain a visual qualitative result and is intended for laboratory use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug 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) analysis is preferred.

Acro Rapid MDMA Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of MDMA in human urine at a cutoff of 500 ng/mL.

TesTcup II and CupKit products are in vitro diagnostics tests intended for professional use for the qualitative detection of drug or drug metabolite in urine at or above the stated cutoff concentrations: Cutoff Concentrations: - Amphetamines: 1000 ng/mL - Benzodiazepines: 200 ng/mL - Cocaine metabolite: 300 ng/mL - Methamphetamine: 500 ng/mL - Methamphetamine: 300 ng/mL - Morphine: 300 ng/mL - Morphine (M2K): 2000 ng/mL - Phencyclidine (PCP): 25 ng/mL - Tetrahydrocannabinols: 50 ng/mL TesTcup II and CupKit products provide only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.

The OnTrak TesTcup II and OnSite Cupkit assays contained in this submission are in vitro diagnostic tests intended for professional use in the qualitative detection of amphetamines (d,1-amphetamine 1000 ng/mL), benzodiazepines (oxazepam 200 ng/mL), cocaine metabolite (benzoylecgonine 300 ng/mL), methamphetamine (d-methamphetamine 500 ng/mL), and methamphetamine (d-methamphetamine 300 ng/mL), morphine (morphine 300 ng/mL), and morphine (morphine 2000 ng/mL), PCP (phencyclidine 25 ng/mL) and THC (11-nor-Δ'-THC-9-carboxylic acid 50 ng/mL). The assays are based on the principle of microparticle capture inhibition. The test relies on the competition between drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane in the test chamber. Urine is collected directly in the test cup provided. The drug profile card is placed in the samples by inserting it into the lid holder, then securing the lid onto the cup. Urine is drawn in the profile card by capillary action and reacts with antibody-coated microparticles and drug conjugate present on the membrance. In the absence of drug, the antibody is free to interact with the drug conjugate, causing the formation of a blue band. When drug is present in the specimen, it binds to the antibody-coated microparticles. If sufficient drug is present, the microparticles are inhibited from binding the drug conjugate and no blue band is formed at the result window. A preliminary positive ("non-negative") result is the absence of a blue band. An additional antibody/antigen reaction occurs at the "VALID" area. The "VALID" blue band forms when antibodies, which are imbedded in the reagent membrane, interact with and bind to the antigen on the blue microparticles.

Acro Rapid Methamphetamine Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of Methamphetamine in human urine at a cutoff of 500 ng/mL. The test is used to obtain a visual qualitative result and is intended for laboratory use only. This assay provides only preliminary results. Clinical consideration and professional judgment must be applied to a drug 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) analysis is preferred.

Acro Rapid Methamphetamine Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of Methamphetamine in human urine at a cutoff of 500 ng/mL.