Search Results

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.

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.

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.

The CLUNGENE Fentanyl Home Test Cassette is competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentany] in human urine at the cut off concentration of 1.0 ng/mL. This test provides only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS) is the preferred confirmatory method. Evaluate preliminary positive results carefully. For in vitro diagnostic use only. The CLUNGENE Fentanyl Test Cassette is competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl in human urine at the cut off concentration of 1.0 ng/mL. This test provides only a preliminary result. A more specific alternative chemical 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. For in vitro diagnostic use only.

The CLUNGENE Fentanyl Tests are immunoassays intended for the qualitative detection of fentanyl in human urine. Each CLUNGENE Fentanyl Test device consists of a Test Cassette, a Dropper and a package insert. Each Test Cassette is sealed with sachets of desiccant in an aluminum pouch.

BioSieve™ Fentanyl FIA Home Test Kit is a fluorescence immunoassay (FIA) for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with BioSieve™ Toxismart Reader. 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 or LC/MS is the preferred confirmatory method. BioSieve™ Fentanyl FIA Pro Test Kit is a fluorescence immunoassay (FIA) for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with BioSieve™ Toxismart Reader. It is for in vitro diagnostic use only. The tests provide only preliminary results. A more specific alternative chemical 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 exercised with any drug test result, particularly when the preliminary test result is positive. BioSieve™ Toxismart Reader is a portable fluorescence instrument for in vitro diagnostic use only. The Reader is designed to perform in vitro diagnostic tests on urine specimens. This Reader is intended for OTC use.

BioSieve™ Fentanyl FIA Home Test Kit and BioSieve™ Fentanyl FIA Pro Test Kit are immunoassays intended for the qualitative detection of fentanyl in human urine. These candidate test kits are the same physical devices as the predicate device cleared in K240124. Each BioSieve™ Fentanyl Test Kit consists of a test cassette and a package insert. Each test cassette is sealed with sachets of desiccant in an aluminum pouch. BioSieve™ Toxismart Reader is a portable fluorescence instrument that is intended for use with the BioSieve™ Fentanyl FIA Home Test Kit and BioSieve™ Fentany] Pro Test Kit. The Reader scans the test cassettes included in the Test Kits and displays the results.

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.

The SAFElife™ Fentanyl Urine Home Test (Cassette) is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at cutoff concentration of 1 ng/mL. For in vitro diagnostic use. For Over The Counter (OTC) use. The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method. The SAFElife™ Fentanyl (FTY) Urine Test Cassette is a competitive binding, lateral flow immunochromatoqraphic assay for qualitative detection of Fentanyl (FTY) in human urine at cutoff concentration of 1 ng/mL. For in vitro diagnostic use. lt is not intended to distinquish between prescription drug or abuse of the drug. Clinical consideration and professional judgment should be applied to the drug of abuse test result, particularly in evaluating a preliminary positive result. The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method. The SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card) is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at cutoff concentration of 1 ng/mL. For in vitro diagnostic use. For Over The Counter (OTC) use. The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method. The SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl (FTY) in human urine at cutoff concentration of 1 ng/mL. For in vitro diagnostic use. It is not intended to distinguish between prescription drug or abuse of the drug. Clinical consideration and professional judgment should be applied to the drug of abuse test result, particularly in evaluating a preliminary positive result. The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical must be used. Chromatography/Mass Spectrometry (GC/ MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method.

The Wondfo SAFElife™ Fentanyl Tests are immunoassays intended for the qualitative detection of fentanyl in human urine. Each Wondfo SAFElife™ Fentanyl Test consists of a Test Device in format of Cassette or Dip Card, and a package insert. Each Test Device is sealed with sachets of desiccant in an aluminum pouch.

Rapid Urine Fentanyl (FYL) Test Strip is a rapid, screening test for the qualitative detection of Fentanyl (FYL) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only. This assay provides only a preliminary analytical test result. 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. Rapid Urine Fentanyl (FYL) Test Dipcard is a rapid, screening test for the qualitative detection of Fentanyl (FYL) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only. This assay provides only a preliminary analytical test result. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS is the preferred confirmatory method.

Rapid Urine Fentanyl (FYL) Test Strip and Rapid Urine Fentanyl (FYL) Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of fentanyl at or above the cut-off concentration of 1 ng/mL. The tests can be performed without the use of an instrument. Test Strip and Test Dipcard use identical test strips made with same chemical formulation and manufacturing procedures.