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Hightop® Home Use Fentanyl Urine Rapid Test Panel is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of fentanyl, the major metabolite of fentaryl in human urine at the cut-off concentrations listed below: | Analyte | Cut-off Level | |--------------------|---------------| | Fentanyl (FYL) | 1ng/mL | | Norfentanyl (NFYL) | 5ng/mL | The test is available in a single test of FYL or a Double panel of FYL and NFYL. It is intended for OTC use. The test provides only a preliminary test result. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. Hightop® Fentanyl/Norfentany] Urine Rapid Test Panel is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of fentanyl, the major metabolite of fentanyl in human urine at the cut-off concentrations listed below: | Analyte | Calibrator | Cut-off level | |--------------------|-------------|---------------| | Fentanyl (FYL) | Fentanyl | 1ng/mL | | Norfentanyl (NFYL) | Norfentanyl | 5ng/mL | The test is available in a single test of FYL or NFYL or a Double panel of FYL and NFYL. The test panel provides only a preliminary test result. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The test panel is not intended to distinguish between prescription use or abuse of fentanyl. Clinical consideration and professional judgment should be applied to the test result, particularly in evaluating a preliminary positive result.

The Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel and Hightop® Fentanyl Norfentanyl Urine Rapid Test Panel are immunoassays intended for the qualitative detection of fentanyl and norfentany] in human urine. Each Hightop® fentanyl 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.

Hightop® Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethy1-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off level | |----------------------------------------------------------|-------------------------| | Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL | | Buprenorphine (BUP) | 10 ng/mL | | Secobarbital (BAR) | 300 ng/mL | | Oxazepam (BZO) | 300 ng/mL | | Cocaine (COC) | 300 ng/mL or 150 ng/mL | | 2-ethylidene-1,5-dimethy1-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL | | Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | | Morphine (MOP 300/OPI 2000) | 2000 ng/mL or 300 ng/mL | | Methadone (MTD) | 300 ng/mL | | Oxycodone (OXY) | 100 ng/mL | | Phencyclidine (PCP) | 25 ng/mL | | Propoxyphene (PPX) | 300 ng/mL | | Nortriptyline (TCA) | 1000 ng/mL | | Marijuana (THC) | 50 ng/mL | Hightop® Multi-Drug Urine Test Cup offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may vield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone 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. Hightop® Multi-Drug Urine Test Cup Rx tests are competitive binding. lateral flow immunochromatographic assavs for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off level | |----------------------------------------------------------|-------------------------| | Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL | | Buprenorphine (BUP) | 10 ng/mL | | Secobarbital (BAR) | 300 ng/mL | | Oxazepam (BZO) | 300 ng/mL | | Cocaine (COC) | 300 ng/mL or 150 ng/mL | | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL | | Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | | Morphine (MOP 300/OPI 2000) | 2000 ng/mL or 300 ng/mL | | Methadone (MTD) | 300 ng/mL | | Oxycodone (OXY) | 100 ng/mL | | Phencyclidine (PCP) | 25 ng/mL | | Propoxyphene (PPX) | 300 ng/mL | | Nortriptyline (TCA) | 1000 ng/mL | | Cannabinoids (THC) | 50 ng/mL | Hightop® Multi-Drug Urine Test Cup Rx offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for prescription use. The tests may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone 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.

The Hightop® Multi-Drug Urine Test Cup and Hightop® Multi-Drug Urine Test Cup Rx are rapid, single-use in vitro diagnostic devices. Each test kit contains a test device in one pouch. One pouch contains a test Hightop® Cup and two desiccants, and a package insert. The Hightop® Multi-Drug Urine Test Cup is intended for over-the-counter use and the Hightop® Multi-Drug Urine Test Cup Rx is intended for prescription use.

HIGHTOP Pregnancy Rapid Test Cassette is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy. HIGHTOP Pregnancy Rapid Test Strip is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy. HIGHTOP Pregnancy Rapid Test Midstream is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.

HIGHTOP Pregnancy Rapid Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine for the detection of pregnancy. The test devices are in three different formats: Strip, Cassette and Midstream. Each test kit contains a test device sealed in a desiccated aluminum pouch and a package insert. The cassette format also contains a dropper.