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FaStep Pregnancy Rapid Test Cassette is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in the early detection of pregnancy. For over-the-counter use. The Fastep HCG Rapid Test Cassette is a rapid visual immunoassay for the qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in the early detection of pregnancy. The test kits are for health care professionals use including professionals at physician's office labs (POLs).

The FaStep Pregnancy Rapid Test Cassette and the Fastep HCG Rapid Test Cassette are the same device with the first intended for over-the counter use and the second for prescription use. The devices contain individually wrapped pouches containing the device, instructions for use, and pipette droppers. The devices utilize a combination of antibodies to detect hCG in urine as well as to serve as a run control. The result is displayed to the user in the test window as two lines for a 'Pregnant' positive result and one line for a 'Not Pregnant' negative result.

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.

FaStep Early Pregnancy Rapid Test Strip is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). For over thecounter use. FaStep Early Pregnancy Rapid Test Cassette is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). For over thecounter use. FaStep Early Pregnancy Rapid Test Midstream is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). For overthe-counter use.

FaStep Early Pregnancy Rapid Test will be sold in Strip, Cassette and Midstream format. The Strip format is a single test strip. The Cassette format consists of a single test strip assembled in a plastic housing. The Midstream format consists of a single test strip assembled in a plastic housing with an absorbent tip, and is designed to be tested in dip or midstream mode. FaStep Early Pregnancy Rapid Test Strip, FaStep Early Pregnancy Rapid Test Cassette and FaStep Early Pregnancy Rapid Test Midstream each contains a pouch with the device and instructions, and in addition, cassette format is packaged with pipette dropper. The devices utilize a combination of antibodies to detect hCG in urine as well as to serve as a run control. Each device contains mouse monoclonal anti-ß-hCG antibody colloidal gold conjugate pre-dried on the sample pad. Mouse monoclonal anti-a-hCG antibody (on the Test Line) and goat anti mouse IgG polyclonal antibody (on the Control Line) are coated and immobilized on a nitrocellulose membrane. The result is displayed to the user in the test window as two lines for a 'Pregnant' positive result and one line for a 'Not Pregnant' negative result.

The FaStep™ Fentanyl Rapid Test Device (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of Fentanyl in human urine specimens at a cut-off concentration of 1.0 ng/mL. It is for in vitro diagnostic use only. The tests provide 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. The FaStep™ Rapid Fentanyl Urine Test (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of Fentanyl in human urine specimens at a cut-off concentration of 1.0 ng/mL. It is for in vitro diagnostic use only. The tests provide 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. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The FaStep™ Fentanyl Tests are immunoassays intended for the qualitative detection of fentanyl in human urine. Each FaStep™ 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.