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The Carolina Liquid Chemistries Cocaine Metabolite Enzyme Immunoassay (COCM) Test System is intended for the qualitative determination of benzoylecgonine (cocaine metabolite) in human urine at a cutoff value of 300 ng/mL. The assay is designed for professional use with a Carolina Liquid Chemistries CLC6410 automated clinical chemistry analyzer. For in vitro diagnostic use only. The assay provides a rapid screening procedure for determining the presence of benzoylecgonine in urine. The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical considerations and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

The Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System is a ready-to-use, liquid reagent homogeneous enzyme immunoassay for qualitatively determining the presence of cocaine metabolite (benzoylecgonine) in human urine. The assay uses specific antibody that can detect benzoylecgonine in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs. The assay is based on competition between benzoylecgonine labeled with the enzyme glucose-6phosphate dehydrogenase (G6PDH) and free drug from the urine sample, for a fixed amount of antibody. In the absence of free drug from the urine sample, the specific antibody binds to the drug labeled with G6PDH causing a decrease in enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD+) to NADH.

The Alinity c Cocaine assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semi-quantitative determination of benzoylecgonine (Cocaine Metabolite) in human urine at a cutoff concentration of either 150 ng/mL or 300 ng/mL on the Alinity c analyzer. The semiquantitative application is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures. The assay provides only a preliminary analytical test 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/ Tandem Mass Spectrometry (LC-MS/MS) are the preferred confirmatory method. Tests for cocaine metabolite cannot distinguish between abused drugs and certain prescribed medications. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.

The DRI Cocaine Metabolite Assay is a homogeneous enzyme immunoassay using ready-to-use liquid reagents. The assay uses a specific antibody, which can detect benzoylecgonine in urine. The assay is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the drug from the urine samplefor a fixed amount of specific antibody binding sites. In the presence of free drug fromthe sample, the free drug occupies the antibody binding sites, allowing the drug-labeled G6PDH to interact with the substrate, resulting in enzyme activity. In the absence of drug from the sample, the specific antibody binds to the drug labeled with G6PDH and the enzyme activity is inhibited. This phenomenon creates a direct relationship between the drug concentration in the urine and the enzyme activity. The enzyme G6PDH activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH. The assay consists of reagents (A and E). Reagent A: Contains mouse monoclonal anti-benzoylecgonine antibody, glucose-6- phosphate (G6P), and nicotinamide adenine dinucleotide (NAD) in Tris buffer with sodium azide as preservative. Reagent E: Contains benzoylecgonine analog labeled with glucose-6-phosphate dehydrogenase (G6PDH) in HEPES buffer with sodium azide as preservative.

The Pointe Scientific Cocaine Metabolite Enzyme Immunoassay is intended for the qualitative determination of benzoylecgonine (a cocaine metabolite) in human urine at a cutoff value of 150 ng/mL. Rx only. This assay provides only a preliminary analytical test result. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatograph/Mass Spectrometry (GC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The Cocaine Metabolite Enzyme Immunoassay consists of ready-to-use liquid reagents: - . Reagent 1 contains a mouse monoclonal anti-benzoylecgonine antibody, glucose-6-phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers and sodium azide (0.09%) as a preservative. - Reagent 2 contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with . benzoylecgonine in buffer with sodium azide (0.09%) as a preservative. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. 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 drug in the sample, benzoylecgonine-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when drug is present in the sample, antibody binds to the free drug; the unbound benzovlecgonine-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 a 340 nm primary wavelength. The assay has a cutoff of 150 ng/mL benzoylecqonine.

The DRI Cocaine Metabolite Assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semi- quantitative determination of benzoylecgonine (Cocaine Metabolite) in human urine at a cutoff concentration of either 150 ng/mL or 300 ng/mL. The semi-quantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/tandem mass spectrometry (LC- MS/MS) or permitting laboratories to establish quality control procedures. The assay provides only a preliminary analytical test 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/ tandem mass spectrometry (LC-MS/MS) is the preferred confirmatory method. Tests for cocaine metabolite cannot distinguish between abused drugs and certain prescribed medications. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.

The DRI Cocaine Metabolite Assay is a homogeneous enzyme immunoassay using ready-to-use liquid reagents. The assay uses a specific antibody, which can detect benzoylecgonine in urine. The assay is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the drug from the urine sample for a fixed amount of specific antibody binding sites. In the presence of free drug from the sample, the free drug occupies the antibody binding sites, allowing the drug-labeled G6PDH to interact with the substrate, resulting in enzyme activity. In the absence of drug from the sample, the specific antibody binds to the drug labeled with G6PDH and the enzyme activity is inhibited. This phenomenon creates a direct relationship between the drug concentration in the urine and the enzyme activity. The enzyme G6PDH activity is determined spectrophotometrically at 340 mm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH. The assay consists of reagents (A and E). Reagent A: Contains mouse monoclonal anti-benzoylecgonine antibody, glucose-6-phosphate (G6P), and nicotinamide adenine dinucleotide (NAD) in Tris buffer with sodium azide as preservative. Reagent E: Contains benzoylecgonine analog labeled with glucose-6-phosphate dehydrogenase (G6PDH) in HEPES buffer with sodium azide as preservative.

The Emit® II Plus Cocaine Metabolite Assay is a homogeneous enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of benzoylecgonine (cocaine metabolite) in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers. The Emit® II Plus Cocaine Metabolite Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used 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 used.

The Emit II Plus Cocaine Metabolite assay is a homogeneous enzyme immunoassay that qualitatively and semiquantitatively measures benzoylecgonine. The assay has cutoffs of 150 ng/mL and 300 ng/mL benzoylecgonine. The assay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that is measured spectrophotometrically at 340 nm. The Emit II Plus Cocaine Metabolite Assay consists of two ready-to-use reagents: Antibody/Substrate Reagent 1 Sheep polyclonal antibodies to benzoylecgonine (2.2 µg/mL), bovine serum albumin, G6P (15 mM), NAD (12 mM), preservatives, and stabilizers Enzyme Reagent 2 Benzoylecgonine labeled with bacterial G6PDH (0.46 U/mL), HEPES buffer, bovine serum albumin, preservatives, and stabilizers

The Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) is for the qualitative determination of benzoylecgonine (cocaine metabolite) in human urine at a cutoff value of 300 ng/mL. The assay is designed for professional use with a clinical chemistry analyzer. For in vitro diagnostic use only. This assay provides a rapid screening procedure for determining the presence of benzoylecgonine in urine. The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical considerations and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

Carolina Liquid Chemistries Cocaine Metabolite Test System (COCM) is a ready-to-use, liquid reagent, homogenous enzyme immunoassay. The assay uses a specific antibody that can detect benzoylecgonine (cocaine metabolite) in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs. The assay is based on competition between benzoylecgonine and glucose-6-phosphate dehydrogenase (G6PDH) enzyme, and free drug from the urine sample for a fixed amount of the specific antibody. In the absence of free drug from the urine sample the specific antibody binds to the drug labeled with G6PDH enzyme causing a decrease in enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically and 340nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.

The MP DOA-10 Panel Test Cup and the MP DOA-11 Panel Test Cup are immunochromatographic one-step in-vitro tests intended for the qualitative detection of up to ten or eleven different drug substances, respectively, in human urine at the following cut-off levels: amphetamine, 1000 ng/ml; barbiturate, 300 ng/ml; benzodiazepine, 300 ng/ml; buprenorphine, 10 ng/ml; cannabinoid, 50 ng/ml; cocaine, 300 ng/ml; methadone, 300 ng/ml; methamphetamine, 1000 ng/ml; opiates, 300/2000 ng/ml; oxycodone, 100 ng/ml and phencyclidine, 25 ng/ml. Only one cutoff concentration will be included per analyte per device. The MP DOA-10 Panel Test Cup and the MP DOA-11 Panel Test Cup may be used in a point-of-care (POC) setting and will provide preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMSHA). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The Rapid Diagnostics MP DOA-10 Panel Test Cup and MP DOA-11 Panel Test Cup are competitive binding, lateral flow immunochromatographic iv-vitro assays for the qualitative and simultaneous detection of amphetamines, barbiturates, benzodiazenines, buprenorphine, cocaine, methadone, methamphetamine, opiates, oxycodone and phencyclidine, in human urine samples. MP DOA-10 Panel Test Cup and MP DOA-11 Panel Test Cup detects each of the analytes on separate strips. A positive urine sample will not generate a colored line for the specific drug tested in the designated region. A negative urine sample containine, barbiturates, benzodiazepines, buprenorphine, cannabinoids, cocaine, methamphetamine, opiates, oxycodone or phencyclidine below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a procedural control, a colored line will always appear at the control region.

The Quest Diagnostics HairCheck-DT (Cocaine) test system utilizes an Enzyme Linked Immunosorbent Assay (ELISA) for the qualitative detection of cocaine in head hair samples through the measurement of cocaine and cocaine metabolites for concentrations at or above 300 pg/mg hair. This test system has not been evaluated for use with hair specimens from locations other than the head. It is an in vitro diagnostic device intended exclusively for in-house professional use and is not intended for sale to anyone. The HairCheck-DT (Cocaine) test system was evaluated in two distinct study populations; individuals known to be chronic drug abusers, and individuals proclaiming to be drug-free. The Quest Diagnostics HairCheck-DT (Cocaine) test system provides only a preliminary analytical test result. To confirm a presumptive screen positive result, a more specific alternate chemical method, such as gas chromatography-mass spectrometry (GC-MS) or Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS), must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

The Quest Diagnostics Hair Check-DT (Cocaine) test system utilizes an Enzyme Linked Immunosorbent Assay (ELISA) for the qualitative detection of cocaine in head hair samples through the measurement of cocaine and cocaine metabolites for concentrations at or above 300 pg/mg hair. This test system has not been evaluated for use with hair specimens from locations other than the head. It is an in vitro diagnostic device intended exclusively for in-house professional use and is not intended for sale to anyone. The ELISA Cocaine Kit is based on the competition for a limited number of antibody sites by unlabeled cocaine/cocaine metabolites and enzyme-labeled drug. The two will bind to the antibody in proportion to their concentration in solution. Once accessioned in the lab, the aluminum foil is opened and the specimen is cut at approxima 3.9 cm from the root end. This specimen is cut into smaller lengths and mixed to ens homogeneity. Ten milligrams of the specimen is weighed out and placed into a properly labeled test tube. The specimen is then washed with methanol, decanted, and then placed in hot methanol containing 0.5% (v/v) trifluoroacetic acid for one hour forty-five minutes. The extracted methanol solution is then transferred to a new tube and evaporated under nitrogen. The tubes are reconstituted with phosphate buffer and assayed using the Cocaine ELISA Kit. This kit is a solid-phase microtiter plate immunoassay in which the microwells are coated with a high affinity capture antibody to cocaine. A hair sample extract is added to the well, followed by the horseradish peroxidase (HRP) enzyme conjugate. During this initial phase, the enzyme conjugate competes with the analyte in the sample for binding sites on the antibody-coated microwells. A wash solution (Tween-20 in phosphate buffered saline solution) is then applied to remove any unbound materials such as excess conjugate and residual sample. Enzyme substrate solution containing 3, 3', 5, 5'-tetramethylbenzidine (TMB) is then added for the final color development process. The reaction is stopped with 1N sulfuric acid and the absorbance is read at 450 nm, with a reference wavelength of 620 nm, using a plate reader. Color intensity is inversely proportional to the amount of analyte present in the sample. Therefore, samples that contain drug or analyte will inhibit binding of the enzyme conjugate to the antibody, resulting in little substrate binding and less color development than in the negative calibrator. For the screening assay an absorbance less than or equal to the absorbance of the 300 pg cocaine/mg hair cutoff calibrator is indicative of the presence of cocaine/cocaine metabolites.

Wondfo Amphetamine Urine Test AMP 500 Cup is an immunochromatographic assay for the qualitative determination of Amphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Amphetamine (calibrator). 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. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. Wondfo Amphetamine Urine Test AMP 500 DipCard is an immunochromatographic assay for the qualitative determination of Amphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Amphetamine (calibrator). 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. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. Wondfo Cocaine Urine Test COC 150 Cup is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 150 ng/mL. This test is callbrated to Benzoylecgonine (calibrator). 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. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. Wondfo Cocaine Urine Test COC 150 DipCard is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 150 ng/mL. This test is callbrated to Benzoylecgonine (calibrator). 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. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. Wondfo Methamphetamine Urine Test MET 500 Cup is an immunochromatographic assay for the qualitative determination of Methamphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Methamphetamine (calibrator). 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. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. Wondfo Amphetamine Urine Test MET 500 DipCard is an immunochromatographic assay for the qualitative determination of Methamphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Methamphetamine (calibrator). 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. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

WONDFO Urine Test devices are immunochromatographic assays for cocaine, amphetamine and Methamphetamine. Each assay test is a lateral flow, one step system for the qualitative detection of Benzoylecgonine, or D-amphetamine or D-methamphetamine (target analyte) in human urine. The product is a single-use in vitro diagnostic device, which comes in the form of: DipCards, or Cups. It contains a Test Device (in one of the two formats), a package insert and a urine cup. Each test device is sealed with a desiccant in an aluminum pouch.

SAFECARE Urine Test Amphetamine Cassette is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL. 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 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. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. SAFECARE Urine Test Amphetamine Cup is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL. 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 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. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. SAFECARE Urine Test Amphetamine DipCard is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL. 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 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. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. SAFECARE Urine Test Cocaine Cassette is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml. 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 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. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. SAFECARE Urine Test Cocaine Cup is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml. 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 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. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. SAFECARE Urine Test Cocaine DipCard is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml. 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 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. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. SAFECARE Urine Test Marijuana Cassette is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL. 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 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. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. SAFECARE Urine Test Marijuana Cup is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL. The tests provide 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. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. SAFECARE Urine Test Marijuana DipCard is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL. The tests provide 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. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test devices are immunochromatographic assays for cocaine, amphetamine and marijuana. Each assay test is a lateral flow, one step system for the qualitative detection of Benzoylecgonine, or D-amphetamine or 11-nor-A9-THC-9 COOH (target analyte) in human urine. The product is a single-use in vitro diagnostic device, which comes in the form of: DipCards, or Cups or Cassettes. It contains a Test Device (in one of the three formats), a package insert and a urine cup. Each test device is sealed with a desiccant in an aluminum pouch.