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The LZI Fentanyl III Enzyme Immunoassay is intended for the qualitative determination of fentanyl in human urine at the cutoff value of 1 ng/mL when calibrated against fentanyl. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatography and mass spectrometry) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

The LZI Fentanyl III Enzyme Immunoassay is a homogeneous enzyme immunoassay with ready-to-use liquid reagents. The assay is based on competition between the drug in the sample and the drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. The drug-labeled G6PDH conjugate is traceable to a commercially available fentanyl standard and referred to as fentanyl-labeled G6PDH conjugate. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of a drug in the sample, fentanyl-labeled G6PDH conjugate is bound to the antibody, and the enzyme activity is inhibited. On the other hand, when the free drug is present in the sample, the antibody would bind to the free drug; the unbound fentanyl-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm. The LZI Fentanyl III Enzyme Immunoassay is a kit comprised of two reagents, R1 and R2, which are bottled separately but sold together within the kit. The R1 solution contains mouse monoclonal anti-fentanyl antibody, glucose-6-phosphate (G6P), nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09%) as a preservative. The R2 solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with fentanyl in buffer with sodium azide (0.09%) as a preservative.

The Deepblue Multi-Drug Urine Test Cup is a rapid lateral flow immunoassay for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, fentanyl, Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: Test | Calibrator | Cut-off(ng/mL) ---|---|--- 6-MAM | 6-Monoacetylmorphine | 10 AMP | d-Amphetamine | 500 or 1000 BAR | Secobarbital | 300 BUP | Buprenorphine | 10 BZO | Oxazepam | 300 COC | Benzoylecgonine | 150 or 300 EDDP | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine | 300 FYL | Fentanyl | 1 MDMA | Methylenedioxymethamphetamine | 500 MET | d-Methamphetamine | 500 or 1000 MTD | d/l-Methadone | 300 MOP/OPI | Morphine | 300 or 2000 OXY | Oxycodone | 100 PCP | Phencyclidine | 25 PPX | d-Propoxyphene | 300 TCA | Nortriptyline | 1000 THC | 11-nor-Δ9-THC-COOH | 50 The single or multi-test cups can consist of up to seventeen (17) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT). The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed presumptive positive 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 Deepblue Home Multi-Drug Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of one or more of the following drugs. Code | Substance | Cut-off(ng/mL) ---|---|--- AMP | Amphetamine | 1000 or 500 BUP | Buprenorphine | 10 BAR | Secobarbital | 300 BZO | Oxazepam | 300 COC | Cocaine | 300 or 150 EDDP | EDDP | 300 FYL | Fentanyl | 1 MET | Methamphetamine | 1000 or 500 MDMA | Ecstasy | 500 OPI | Morphine | 2000 or 300 MTD | Methadone | 300 OXY | Oxycodone | 100 PCP | Phencyclidine | 25 PPX | Propoxyphene | 300 TCA | Nortriptyline | 1000 THC | Marijuana | 50 6-MAM | 6-Monoacetylmorphine | 10 This drug test cup may contain any combination of the drug tests listed in the table above. This test provides only preliminary result. A more specific alternative chemical method must be used to obtain a confirmed presumptive positive 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.

Deepblue Home Muti-Drug Urine Test Cup and Deepblue Muti-Drug Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine. The device is a cup format. Each test device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

AllTest Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Tramadol, Propoxyphene and 6-monoacetylmorphine in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off level | |-------------------|---------------| | Amphetamine (AMP) | 500 ng/mL or 1000 ng/mL | | Buprenorphine (BUP) | 10 ng/mL | | Secobarbital (BAR) | 300 ng/mL | | Benzodiazepine (BZO) | 300 ng/mL | | Cocaine (COC) | 150 ng/mL or 300 ng/mL | | Methamphetamine (MET) | 500 ng/mL or 1000 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | | Morphine (MOP/OPI) | 300 ng/mL or 2000 ng/mL | | Methadone (MTD) | 300 ng/mL | | Oxycodone (OXY) | 100 ng/mL | | Phencyclidine (PCP) | 25 ng/mL | | Nortriptyline (TCA) | 1000 ng/mL | | Marijuana (THC) | 50 ng/mL | | Fentanyl(FYL) | 1 ng/mL | | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL | | Tramadol (TRA) | 100 ng/mL | | Propoxyphene (PPX) | 300 ng/mL | | 6-monoacetylmorphine (6-MAM) | 10 ng/mL | AllTest Multi-Drug Urine Test Cup can be a single drug test cup or used for any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. AllTest Multi-Drug Rapid Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Tramadol, Propoxyphene and 6-monoacetylmorphine in human urine at the cutoff concentrations of: | Drug (Identifier) | Calibrator | Cut-off (ng/mL) | |-------------------|------------|-----------------| | Amphetamine (AMP) | d-Amphetamine | 500 or 1000 | | Buprenorphine (BUP) | Buprenorphine | 10 | | Secobarbital (BAR) | Secobarbital | 300 | | Benzodiazepine (BZO) | Oxazepam | 300 | | Cocaine (COC) | Benzoylecgonine | 150 or 300 | | Methamphetamine (MET) | d-Methamphetamine | 500 or 1000 | | Methylenedioxymethamphetamine (MDMA) | d,l-Methylenedioxymethamphetamine | 500 | | Morphine (MOP/OPI) | Morphine | 300 or 2000 | | Methadone (MTD) | Methadone | 300 | | Oxycodone (OXY) | Oxycodone | 100 | | Phencyclidine (PCP) | Phencyclidine | 25 | | Nortriptyline (TCA) | Nortriptyline | 1000 | | Marijuana (THC) | 11-nor-Δ9-THC-9 COOH | 50 | | Fentanyl (FYL) | Fentanyl | 1 | | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 | | Tramadol (TRA) | Tramadol | 100 | | Propoxyphene (PPX) | Propoxyphene | 300 | | 6-monoacetylmorphine (6-MAM) | 6-monoacetylmorphine | 10 | AllTest Multi-Drug Rapid Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Urine Test Cup and AllTest Multi-Drug Rapid Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine. The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format.

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.

AllTest Multi-Drug Rapid Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Benzodiazepines, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencycline, Nortriptyline, Marijuana, Tramadol, Propoxyphene, Fentanyl and 6monoacetylmorphine in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off level | |---------------------------------------------------------------------------------------------|-------------------| | Amphetamine (AMP) | 500 or 1000 ng/mL | | Buprenorphine (BUP) | 10 ng/mL | | Secobarbital (BAR) | 300 ng/mL | | Benzodiazepines (BZO) | 300 ng/mL | | Cocaine (COC) | 150 or 300 ng/mL | | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL | | Methamphetamine (MET) | 500 or 1000 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | | Morphine (MOP/OPI) | 300 or 2000 ng/mL | | Methadone (MTD) | 300 ng/mL | | Oxycodone (OXY) | 100 ng/mL | | Phencyclidine (PCP) | 25 ng/mL | | Nortriptyline (TCA) | 1000 ng/mL | | Marijuana (THC) | 50 ng/mL | | Tramadol (TRA) | 100 ng/mL | | Propoxyphene (PPX) | 300 ng/mL | | Fentanyl(FYL) | 1 ng/mL | | 6-monoacetylmorphine (6-MAM) | 10 ng/mL | | AllTest Multi-Drug Rapid Test Cup can be a single drug test cup or used for any combination | | est Multi-Drug Rapid Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these crugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. AllTest Multi-Drug Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secodiazepines, Cocaine, 2- ethylidene-1.5dimethyl-3,3- diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Tramadol, Propoxyphene Fentanyl and 6-monoacetylmorphine in human urine at the cutoff concentrations of: | Drug (Identifier) | Calibrator | Cut-off (ng/mL) | |--------------------------------------------------------------|-------------------------------------------------------|-----------------| | Amphetamine (AMP) | d-Amphetamine | 500 or 1000 | | Buprenorphine (BUP) | Buprenorphine | 10 | | Secobarbital (BAR) | Secobarbital | 300 | | Benzodiazepines (BZO) | Oxazepam | 300 | | Cocaine (COC) | Benzoylecgonine | 150 or 300 | | 2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine | 300 | | Methamphetamine (MET) | d-Methamphetamine | 500 or 1000 | | Methylenedioxymethamphetamine (MDMA) | d,l-Methylenedioxymethamphetamine | 500 | | Morphine (MOP/OPI) | Morphine | 300 or 2000 | | Methadone (MTD) | Methadone | 300 | | Oxycodone (OXY) | Oxycodone | 100 | | Phencyclidine (PCP) | Phencyclidine | 25 | | Nortriptyline (TCA) | Nortriptyline | 1000 | | Marijuana (THC) | 1-nor-Δ9-THC-9 COOH | 50 | | Tramadol (TRA) | Tramadol | 100 | | Propoxyphene (PPX) | Propoxyphene | 300 | | Fentanyl(FYL) | Fentanyl | 1 | | 6-monoacetylmorphine (6-MAM) | 6-monoacetylmorphine | 10 | AllTest Multi-Drug Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Rapid Test Cup and AllTest Multi-Drug Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine. The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

Dochek® Multi-Drug Urine Test Cup is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations. Dochek® Multi-Drug Urine Test Cup offers any combinations from 1 to 17 drugs but only one cutoff concentration under same drug condition will be included per device. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a postive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method. Dochek® Multi-Drug Urine Test Cup Pro is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations. Dochek® Multi-Drug Urine Test Cup Pro offers any combinations from 1 to 17 drugs but only one cutoff concentration under same drug condition will be included per device. For in vitro diagnostic use only. The test provides only preliminary results. 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. GC/MS or LC/MS is the recommended confirmatory method.

Dochek® Multi-Drug Urine Test Cup Pro and Dochek® Multi-Drug Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine at or above the cut-off levels as indicated. The products are single use in vitro diagnostic medical devices. This device is a cup format, with the test strips integrated into the plastic cup provided, and the urine sample is collected directly into the cup containing the strips. Each cup device is sealed in an aluminum foil pouch with two sachets of desiccant. The device is in a ready-to-use format and no longer requires assembly before use.

The AssureTech Panel Dip Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Methamphetamine, Fentanyl, Norfentany], Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations listed. The single or multi-test panels can consist of up to seventeen (17) of the above listed analytes in any combination. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. 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. For in vitro diagnostic use only. The AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Methamphetamine, Fentanyl, Norfentany], Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations listed. The single or multi-test panels can consist of up to seventeen (17) of the above listed analytes in any combination. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. 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. For in vitro diagnostic use only. The AssureTech Multi-drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana, Methamphetamine, Morphine, Fentanyl, Norfentanyl, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline, d-Propoxyphene and adulterants in human urine at the cutoff concentrations listed. The single or multi-test panel can consist of up to seventeen (17) of the above listed analytes in any combination. It is for in vitro diagnostic use only. The test provides only preliminary test results. A more specific alternative chemical 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. The AssureTech Multi-drug Urine Test Cup are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Fentanyl, Norfentanyl, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline, d-Propoxyphene and adulterants in human urine at the cutoff concentrations listed. The single or multi-test cups can consist of up to seventeen (17) of the above listed analytes in any combination. It is for in vitro diagnostic use only. 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.

The AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Fentanyl, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP. Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single use in vitro diagnostic devices, which come in the formats of Panel Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

Dochek® Fentanyl Urine Test Strip Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive. Dochek® Fentany] Urine Test Card Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive. Dochek® Fentanyl Urine Test Cup Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive. Dochek® Fentanyl Urine Test Strip is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive. Dochek® Fentanyl Urine Test Card is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive. Dochek® Fentanyl Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.

Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentany1 Urine Test Card, Dochek® Fentany] Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus are immunochromatographic assays that use a lateral flow system for the qualitative detection of fentanyl in human urine. Test Strip, Test Card and Test Cup use identical test strips made with same chemical formulation and manufacturing procedures.

The Healgen® Accurate Multi-Drug Urine Screening Cup is a rapid lateral flow immunoassay for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, Norfentanyl, Methadone, d-Methamphetamine, d/l-Methylenedioxymethamine, Mortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, THC-COOH and Tramadol in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: | Test | Calibrator | Cut-off (ng/mL) | |------------|------------------------------------------------------|-----------------| | 6-MAM | 6-Monoacetylmorphine | 10 | | AMP | d-Amphetamine | 500 or 1000 | | BAR | Secobarbital | 300 | | BUP | Buprenorphine | 10 | | BZO | Oxazepam | 300 | | COC | Benzoylecgonine | 150 or 300 | | EDDP | 2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrolidine | 300 | | FEN or FYL | Norfentanyl | 5 | | MDMA | Methylenedioxymethamphetamine | 500 | | MET | d-Methamphetamine | 500 or 1000 | | MTD | Methadone | 300 | | OPI | Morphine | 300 or 2000 | | OXY | Oxycodone | 100 | | PCP | Phencyclidine | 25 | | PPX | d-Propoxyphene | 300 | | TCA | Nortriptyline | 1000 | | THC | 11-nor-Δ9-THC-COOH | 50 | | TRA or TMI | Tramadol | 100 | The single or multi-test cups can consist of up to eighteen (18) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT). The tests provide only a preliminary result. A more specific alternative chemical must be used to obtain a confirmed positive 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 Healgen® Accurate Home Multi-Drug Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of one or more of the following drugs | CODE | SUBSTANCE | Cut-off (ng/mL) | |------|---------------|-----------------| | AMP | Amphetamine | 1000 or 500 | | BUP | Buprenorphine | 10 | | BAR | Secobarbital | 300 | | BZO | Oxazepam | 300 | | COC | Cocaine | 300 or 150 | | EDDP | EDDP | 300 | | FYL | Norfentanyl | 5 | | MET/mAMP | Methamphetamine | 1000 or 500 | | MDMA | Ecstasy | 500 | | OPI | Morphine | 2000 or 300 | | MTD | Methadone | 300 | | OXY | Oxycodone | 100 | | PCP | Phencyclidine | 25 | | PPX | Propoxyphene | 300 | | TCA | Nortriptyline | 1000 | | THC | Marijuana | 50 | | TML | Tramadol | 100 | | 6-MAM | 6-Monoacetylmorphine | 10 | This drug test cup may contain any combination of the drug tests listed in the table above. This test provides only preliminary result. A more specific alternative chemical must be used to obtain a confirmed positive 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.

Healgen® Accurate Home Muti-Drug Urine Test Cup and Healgen® Accurate Muti-Drug Urine Drug Screen Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine. The device is a cup format. Each test device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

The ETERBIO Fentany]Norfentary] Rapid Test (Colloidal Gold) is an immunoassay intended for the qualitative detection of Fentanyl (FTY) /Norfentanyl (NFTY) in human urine: | Drug (Identifier) | Calibrator | Cut-off Level | |--------------------|-------------|---------------| | Fentanyl (FYL) | Fentanyl | 1ng/mL | | Norfentanyl (NFYL) | Norfentanyl | 5ng/mL | The test is available as a single panel for FYL, or as a dual panel combining both FYL and NFYL. It provides a preliminary screening result only. For a confirmed analytical outcome, a more specific chemical is required. GC/MS or LC/MS is the preferred confirmatory method. The ETERBIO Fentanyl Norfentanyl Home Test is an immunoassay intended for the qualitative detection of Fentanyl (FTY) /Norfentanyl (NFTY) in human urine: | Drug (Identifier) | Calibrator | Cut-off Level | |--------------------|-------------|---------------| | Fentanyl (FYL) | Fentanyl | 1ng/mL | | Norfentanyl (NFYL) | Norfentanyl | 5ng/mL | The test is available as a single panel for FYL, or as a dual panel combining both FYL and NFYL. This test provides only preliminary results. For a confirmed analytical outcome, a more specific chemical method is required. GC/MS or LC/MS is the preferred confirmatory method.

Rapid Test ETERBIO Fentanyl/Norfentanyl Gold) and ETERBIO The Fentanyl/Norfentanyl Home Test are immunoassays intended for the qualitative detection of fentanyl and norfentanyl in human urine. Each ETERBIO fentanyl/norfentanyl urine test device consists of a Test Panel and a package insert. Each Test Panel is sealed with sachets of desiccant in an aluminum pouch.