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The Healstone Accurate ™ Drug of Abuse Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of potential abuse of one or more drugs. This is not a screening device to monitor prescription medication. This drug test cup may contain any combination of the drug tests listed in the table above. This drug tests cup provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. Gas chromatography/mass spectrometry (CCMS) is the preferred method confirmation test. For in vitro diagnostic use only. The Healstone Accurate ™ Drug of Abuse Urine Test Cup Rx is a rapid qualitative immunoassay. The device provides preliminary results for the detection of potential abuse of one or more drugs. This is not a screening device to monitor prescription medication. This drug test cup may contain any combination of the drug tests listed in the table above. This drug tests cup provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. Gas chromatography/mass spectrometry (GC/MS) is the preferred method confirmation test. It is intended for prescription use. For in vitro diagnostic use only.

The Healstone Accurate™ Drug of Abuse Urine Test Cup and Healstone Accurate™ Drug of Abuse 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 Accurate™ Cup and two desiccants, and a package insert. The Healstone Accurate™ Drug of Abuse Urine Test Cup is intended for over-the-counter use and the Healstone Accurate™ Drug of Abuse Urine Test Cup Rx is intended for prescription use.

The hCG One Step Pregnancy Test is an in vitro diagnostic test for the qualitative determination of human chorionic gonadotropin hormone in human urine samples. It is used as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

The hCG One Step Pregnancy Test is a lateral flow sandwich immunochromatographic assay for the qualitative determination of human chorionic gonadotropin (hCG) in human urine samples.

Accurate Multi Panel 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-dimethyl-3,3-diphenylpyrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off | |----------------------------------------------------------|---------| | Amphetamine (AMP) | 1000 ng | | Buprenorphine (BUP) | 10 ng | | Secobarbital (BAR) | 300 ng | | Oxazepam (BZO) | 300 ng | | Cocaine (COC) | 300 ng | | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng | | Methamphetamine (MET) | 1000 ng | | Methylenedioxymethamphetamine (MDMA) | 500 ng | | Morphine (MOP 300/OPI 2000) | 300 ng | | Methadone (MTD) | 300 ng | | Oxycodone (OXY) | 100 ng | | Phencyclidine (PCP) | 25 ng | | Propoxyphene (PPX) | 300 ng | | Nortriptyline (TCA) | 1000 ng | | Marijuana (THC 50) | 50 ng | level /mL /mL /mL /mL z/mL g/mL g/mL /mL g/mL or 2000 ng/mL g/mL g/mL g/mL g/mL g/mL 50 ng/mL Accurate Multi Panel 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. The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when 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.

Accurate® Multi Panel Drug Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine. Each Accurate® Multi Panel Drug Urine Test Cup device consists of a test cup and a package insert. Each test cup is sealed with desiccant in an aluminum pouch.