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The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is a screening test for the qualitative detection of amphetamines, barbiturates, benzodiazepines, cocaine, ecstasy, methadone, methamphetamine, opiates, oxycodone, phencyclidine, marijuana, tricyclic antidepressants (imipramine) and buprenorphine in urine at the cut-off concentrations listed below. Test for barbiturates, benzodiazepine, oxycodone, buprenorphine and tricyclic antidepressants (imipramine) cannot distinguish between abused drugs and certain prescription medications. The test is intended for professional use only.

The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is a screening test for the rapid detection of the following drugs in urine at the cut-off concentrations listed in Table 1. It is a competitive immunoassay that is used to screen for the presence of drugs of abuse in urine. The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is a single-use device utilizing a cup format. The device is based upon the Phamatech At Home 12 Drug Test Models 9308Z cleared in K070009 for home use for the detection of amphetamines(AMP), barbiturates (BAR), benzodiazepines (BZD), cocaine (COC), ecstasy (MDMA), methadone (MTD), methamphetamine(MET), opiates (OPI), oxycodone (OXY), phencyclidine (PCP) and marijuana (THC) in urine samples. The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z adds testing for tricyclic antidepressants (TCA) (imipramine) and buprenorphine (BUP). The QuickScreen Pro Multi-Drug Screening Test System is intended for use in prescription point-of-care settings. The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is a chromatographic absorbent device in which drugs or drug metabolites in a urine sample compete with drug / protein conjugate immobilized on a porous membrane of the test device for a limited number of antibody / dye conjugate binding sites. The test device employs a unique combination of monoclonal and polyclonal antibodies to selectively identify drugs of abuse in urine. The test device also contains a self-timer that indicates when test results are ready to be interpreted.

QuickScreen™ Amphetamine 500 Test Model 9058 (dip card): The QuickScreen Amphetamine 500 Test is a qualitative in-vitro diagnostic screen that provides a preliminary result for the detection/presence of Amphetamine in urine. The cut-off concentration is 500 ng/ml. It is intended for prescription point of care use only. This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed. QuickScreen™ Amphetamine 500 Test Model 9054 (cassette): The QuickScreen Amphetamine 500 Test is a qualitative in-vitro diagnostic screen that provides a preliminary result for the detection/presence of Amphetamine in urine. The cut-off concentration is 500 ng/ml. It is intended for prescription point of care use only. This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed. QuickScreen ™ Multi Drug Screening Test Model 9346T(dip card): The QuickScreen™ Multi Drug Screening Test Model 9346T is an in vitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, oxycodone, PCP, Barbiturates, benzodiazepines, methadone and THC in urine. The test is available in any combination of the drugs or drug metabolites listed below. Tests for barbiturates, benzodiazepine and oxycodone cannot distinquish between abused drugs and certain prescribed medications. The test is intended for prescription point of care use only. This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed. QuickScreen™ Drug Cup Model 9346Z: The QuickScreen™ Drug Cup Model 9346Z is an in vitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, oxycodone, PCP, barbiturates, benzodiazepines, methadone and THC in urine at the cut-off concentrations listed below. The test is available in any combination of the drugs or drug metabolites listed below. Tests for barbiturates, benzodiazepine and oxycodone cannot distinguish between abused drugs and certain prescribed medications. The test is intended for prescription point of care use only. This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.

Immunoassay for the qualitative detection, Amphetamine, THC, Cocaine, PCP, Barbiturates, Benzodiazepines, Methadone, Oxycodone, Opiates and Methamphetamine in urine. The QuickScreen Drug Screening Test system, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology. All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / target drug / antibody / complexes.

The QuickScreen Drug Screening Test System is a rapid, qualitative immunoassay for the detection of amphetamine, barbiturates, benzodiazepines, cocaine, methadone, methamphetamines, opiates, oxycodone, phencyclidine and THC or their metabolites in urine. This assay is intended to assist in the prevention of drug abuse. The QuickScreen Drug Screening Test System is for in-vitro diagnostic use and is intended for use in point-of-care settings. The QuickScreen Cocaine 150 Test is an in-vitro diagnostic test for the detection/presence of cocaine (benzoylecgonine) in urine. The cut-off concentration is 150 ng/ml. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. This test is intended for point-of-care testing. An invitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP, Barbiturates, benzodiazepines, methadone , oxycodone and THC in urine. Tests for barbiturates cannot distinguish between abused drugs and certain prescribed medications. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. This test is intended for point-of-care testing.

The QuickScreen Drug Screening Test system, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology.

The QuickScreen™ Barbiturates Test is a rapid, qualitative immunoassay for the detection of Barbiturates in urine. The cutoff concentration for this test is 300 ngdomly This assay is intended for professional use. QuickScreen Multi Drug Screening Test is a rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine. The cut-off concentrations of this test are as follows: Amphetamine; 1000 ng/ml Barbiturates: 300 nq/ml Benzodiazepines: 200 na/ml Cocaine; 300 ng/ml Methadone 300 nq/ml Methamphetamine; 1000 ng/ml Opiates: 2000 ng/ml. Phencyclidine (PCP) 25 ng/ml THC: 50 nq/ml This assay is intended to assist in the prevention of drug abuse The QuickScreen Barbiturates Test is a qualitative in-vitro diagnostic screen that provides a preliminary result for the detection/presence of Barbiturates in urine. Tests for barbiturates cannot distinguish between abused drugs and certain prescribed medications. The cut-off concentration will be 300 ng/ml (secobarbital). It is intended for professional use only. An invitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP, Barbiturates, benzodiazepines, methadone and THC in urine. Tests for prescription drugs cannot distinguish between abused drugs and certain prescribed medications. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. It is intended for professional use only.

Immunoassay for the qualitative detection of Barbiturates in urine Immunoassay for the qualitative detection, Amphetamine, THC, Cocaine, PCP, Barbiturates, Benzodiazepines, Methadone, Opiates and Methamphetamine in urine

The Moments Menopause Check is an in-vitro diagnostic screen for the detection of FSH (follicle stimulating hormone) in urine. Change in FSH levels may be associated with changes in menopause. This kit provides a preliminary screening result. This kit is intended for over-the-counter sales.

Immunoassay for the qualitative detection of FSH in urine.

The QuickScreen™ Oxycodone Test is a rapid, qualitative immunoassay for the detection of Oxycodone in urine. The cutoff concentration for this test is 100 ng/mL.. This test is intended for professional use. This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.

Immunoassay for the qualitative detection of Oxycodone in urine. The QuickScreen™ Oxycodone Test, like many commercially available oxycodone screening test kits, qualitatively measures the presence of oxycodone by visual color sandwich one step immunoassay technology. These devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibodv / target analyte / antibody / complexes.

The QuickScreen™ Benzodiazepines Test is a rapid, qualitative immunoassay for the detection of benzodiazepines in urine. The cutoff concentration for this test is 200 ng/ml. This assay is intended for professional use. The QuickScreen Benzodiazepines Test is an in-vitro diagnostic screen that provides a qualitative detection of benzodiazepines in urine. It is intended for professional use only. An invitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP, benzodiazepines, barbiturates, methadone and THC in urine. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. It is intended for professional use only.

Immunoassay for the qualitative detection of Benzodiazepines in urine The QuickScreen™ Benzodiazepines Test, like many commercially available oxycodone screening test kits, qualitatively measures the presence of benzodiazepines by visual color sandwich one step immunoassay technology. These devices rely on the basic immunochemical sandwich assay principle of recognition of specific antibody / target analyte / antibody / complexes.

The Moments Menopause Check is an in-vitro diagnostic screen for the detection of FSH (follicle stimulating hormone) in urine. Change in FSH levels may be associated with stages in menopause. This kit provides a preliminary result for the detection/presence of FSH in urine. It is intended for over-the-counter sales.

Immunoassay for the qualitative detection FSH (follicle stimulating hormone) in urine. The Moments Menopause Check, like many commercially available FSH screening test kits, qualitatively measures the presence of FSH by visual color sandwich one step immunoassay technology.

The Phamatech At Home Ovulation Test is a rapid qualitative test for the detection of luteinizing hormone (LH) in urine. The cut-off concentration for this test is as follows: LH at 30mlU/mL. This assay is intended for use in the home to assist in determining the ovulation cycle. The Phamatech At Home Ovulation Test is intended for over the counter use.

Immunoassay for the qualitative detection of LH in urine. The At HOME OVULATION TEST, like many commercially available ovulation test kits, qualitatively measures the presence of luteinizing hormone by visual color sandwich one step immunoassay technology. All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / LH / colored (labeled) antibody complexes.