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The Labcorp Fentanyl Urine Visual Test is a lateral flow competitive immunoassay for the rapid qualitative detection of norfentanyl (fentanyl metabolite) in human urine at a cutoff of 5 ng/mL. It is intended for prescription use. For in vitro diagnostic use only.

This test provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug test result, particularly in evaluating a preliminary positive result. To confirm preliminary positive results, a more specific analytical method must be used. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS), and High Performance Liquid Chromatography (HPLC) are the preferred confirmatory methods.

The Labcorp Fentanyl Urine Visual Test (the "DEVICE") is a lateral flow competitive immunoassay for the rapid qualitative detection of Norfentanyl (nFEN), the primary urinary metabolite of Fentanyl, in human urine at concentrations above 5 ng/mL. It is intended for prescription use.

The single use, in vitro diagnostic DEVICE is available in a cassette format with a disposable dropper provided for sample transfer.

The DEVICE contains a test strip that gives a qualitative result for presence of Norfentanyl in human urine. The DEVICE is read visually and has labeling with instructions for interpreting test results.

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The Evidence MultiSTAT DOA Urine MultiPlex is intended for use with the Evidence MultiSTAT. The Evidence MultiSTAT is an analyser intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine at the associated cut offs.

The Evidence MultiSTAT DOA Urine MultiPlex detects the following drugs at the following cut offs:

The Evidence MultiSTAT DOA Urine Multiplex 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) and/or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS) and the preferred confirmatory methods. Other chemical confirmation methods are available. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

For In Vitro Diagnostic use only.

FOR PRESCRIPTION USE ONLY

The Evidence MultiSTAT analyzer is a benchtop fully automated Biochip Array System. It performs simultaneous detection of multiple analytes from a single sample. The core technology is the Randox Biochip, a solid-state device containing an array of discrete test regions containing immobilized antibodies specific to different Drugs of Abuse (DOA) compound classes. A competitive chemiluminescent immunoassay is used for the DOA assays with the drug in the specimen and drug labelled with horseradish peroxidase (HRP) being in direct competition for the antibody binding sites. Increased levels of drug in a specimen will lead to reduced binding of drug labelled with HRP and thus a reduction in chemiluminescence being emitted. The light signal generated from each of the test regions on the biochip is detected by a Charge Coupled Device (CCD) camera in the Evidence MultiSTAT system which, together with the analyzer software, is used to quantify the light output and produce meaningful results.

The immunoassay processes are performed automatically in a self-contained and sealed biochip cartridge, which holds the biochips, the reagents, wash buffer and other fluids required for the test to be conducted.

Evidence MultiSTAT assays employ a qualitative reporting method. Each test sample is assayed against the provided Cut Off material of known concentration, which is used to determine the classification of the samples based on the comparison of the signal output.

The Evidence MultiSTAT DOA Urine MultiPlex (EV4393) will be supplied as a test kit comprising:

• 12 x Urine Test Cartridges
• 6 x 1 ml Urine Cut Off Material (lyophilized)
• 4 x 1 ml Urine Positive Control Material (lyophilized)
• 2 x 10 ml Reconstitution Buffer
• 1 x Batch Barcodes

Each kit is supplied with the Evidence MultiSTAT Accessory kit (EV4116) which contains:

• 12 x MultiSTAT Tip Cartridges
  • 1 x Tip/Waste Cartridge
  • 6 x 1000 µl Pipette Tip
  • 1 x Liquid Absorber

Reagent Composition
MultiSTAT DOA Urine MultiPlex Assay Diluent
20 mM phosphate buffer, pH 7.0 containing protein, detergents, and preservatives. This is contained within the cartridge.

MultiSTAT DOA Urine MultiPlex Conjugate
20 mM Tris based buffer, pH 7.0 containing protein, preservatives, and horseradish peroxidase - labelled drug derivatives. This is contained within the cartridge.

MultiSTAT DOA Urine MultiPlex Biochip
Solid substrate containing immobilized antibody discrete test regions. This is contained within the cartridge.

MultiSTAT DOA Urine MultiPlex Wash Buffer
20 mM Tris buffered saline, pH 7.4, containing surfactant and preservatives. This is contained within the cartridge.

LUM-EV934/PX
Luminol-EV934 and Peroxide are contained within the cartridge and are mixed in a ratio of 1:1 by the analyser to give the working signal reagent

MultiSTAT DOA Urine MultiPlex Cut Off
Lyophilised, 20 mM phosphate buffer, pH 7.2 containing stabilizers, preservatives and drug concentrations at the assay cut off values (detailed in Table 3 above).

MultiSTAT DOA Urine MultiPlex Positive Control
Lyophilised, 20 mM phosphate buffer, pH 7.2 containing stabilizers, preservatives, and drug concentrations.

MultiSTAT Reconstitution Buffer
A solution at a neutral pH containing preservatives.

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The LZI Buprenorphine II Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of norbuprenorphine in human urine at the cutoff value of 5 ng/mL when calibrated against norburprenorphine. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.

The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) or (2) permitting laboratories to establish quality control procedures

The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatography and mass spectrometry) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

The LZI Buprenorphine II Enzyme Immunoassay is a homogeneous enzyme immunoassay ready-to-use liquid reagent. 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, norbuprenorphine-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 would bind to free drug; the unbound norbuprenorphine-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 340 nm.

The LZI Buprenorphine II Enzyme Immunoassay is a kit comprised of two reagents, R₁ and R₂, which are bottled separately but sold together within the kit.

The R₁ solution contains mouse monoclonal anti-norbuprenorphine antibody, glucose-6-phosphate (G6P), nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09%) as a preservative. The R₂ solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with norbuprenorphine in buffer with sodium azide (0.09%) as a preservative.

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The Healgen Accurate Urine Drug Screen Dip Card is a rapid lateral flow immunoassays for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, d/l-Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, THC-COOH, Norfentanyl and Tramadol in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

The single or multi-test panels 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 method 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 Urine Drug Test Dip Card is a rapid qualitative immunoassay. The device provides preliminary results for the detection of potential abuse of one or more drugs in human urine at the cutoff concentrations of table below.

This is not a screening device to monitor prescription medication.

This drug test dip card may contain any combination of the drug tests listed in the table above but only one cutoff concentration under same drug condition will be included per device.

This test provides only preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. GC/MS or LC/MS is the preferred confirmatory method. Evaluate preliminary positive results carefully.

Healgen Accurate Home Urine Drug Test Dip Card and Healgen Accurate Urine Drug Screen Dip Card 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 dip card 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.

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SAFElife™ T-Cup Multi-Drug Urine Test Cup:

SAFElife™ T-Cup Multi-Drug Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of 6-Monoacetylmorphine, Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Fentanyl, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Opiates, Methadone, Norfentanyl, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Cannabinoids and Tramadol in human urine at the cutoff concentrations of:

SAFElife™ T-Cup Multi-Drug Urine Test Cup offers any combinations from 1 to 19 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.

The tests may yield positive results for the prescription drugs Buprenorphine, Fentanyl, Nortriptyline, Oxazepam, Secobarbital, Oxycodone and Tramadol when taken 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. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the recommended confirmatory method.

SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx:

SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of 6-Monoacetylmorphine, Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Fentanyl, Methylenedioxymethamphetamine, Methamphetamine, Morphine, Opiates, Methadone, Norfentanyl, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Cannabinoids and Tramadol in human urine with below cutoff
concentrations and approximate detection time:

SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx offers any combinations from 1 to 19 drugs of abuse tests with or without on-board adulteration/specimen validity test (SVT) but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use.

The tests may yield positive results for the prescription drugs Buprenorphine, Fentanyl, Nortriptyline, Oxazepam, Secobarbital, Oxycodone and Tramadol when taken 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. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the recommended confirmatory method.

SAFElife™ T-Cup Multi-Drug Urine Test Cup and SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Opiates, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Cannabinoids, 6-Monoacetylmorphine, Fentanyl, Norfentanyl, and Tramadol in human urine. Each SAFElife™ T-Cup Multi-Drug Urine Test Cup or SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx device consists of a test cup and a package insert. Each test cup is sealed with one sachet of desiccant in an aluminum pouch. SAFElife™ T-Cup Multi-Drug Urine Test Cup and SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx have a general identical design. The SAFElife™ T-Cup Multi-Drug Urine Test Cup is for over-the-counter (OTC) use and the SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx is for professional use.

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The VINScreen Urine Drug Test Cup is lateral flow immunoassays for rapid detection of multiple commonly abused drugs in human urine. The detectable drugs and their cutoff concentrations are listed below:

The single or multi-test cup can include any combination of the analytes listed above, with and without on-board adulteration tests. However, only one cut-off concentration can be included per analyte per device.

This in vitro diagnostic device provides only a preliminary test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical test result. GC/MS or LC/MS is the preferred confirmatory method.

The VINScreen Urine Drug Home Test Cup is lateral flow immunoassays for rapid detection of multiple commonly abused drugs in human urine. The detectable drugs and their cutoff concentrations are listed below:

The single or multi-test cup can include any combination of the analytes listed above, with and without on-board adulteration tests. However, only one cut-off concentration can be included per analyte per device.

This device provides only a preliminary test result. A more specific alternate method must be used in order to obtain a confirmed analytical test result. GC/MS or LC/MS is the preferred confirmatory method.

VINScreen Urine Drug Test Cup and VINScreen Urine Drug Home Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.

The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

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SOBER SELF-TEST is a qualitative screening test used to detect the presence of ethyl alcohol in human saliva. The test detects relative blood alcohol concentrations (BAC) greater than or equal to 0.02%. Results are used for the diagnosis of alcohol intoxication. For in-vitro diagnostic use. The assay is a disposable test for one-time use.

Sober Self-Test® strips are a visually read qualitative test for the detection of alcohol concentration in saliva. It consists of a visually interpreted test strip that develops a distinct blue color on the test pad when wet with human saliva that has a Alcohol Concentration (AC) equal to or greater than 0.02%. The device consists of a single test in a foil packet or in boxes of three, six, twelve, or 24 boxes of single test packets, each designed for one-time use only.

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Wisdiag Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Marijuana, Tramadol, Fentanyl, 6-Monoacetylmorphine and Norfentanyl in human urine at the cutoff concentrations of:

The single or multi-test cups can consist of up to nineteen (19) of the above listed analytes in any combination but only one cutoff concentration under same drug condition will be included per device with or without on-board adulteration/specimen validity tests (SVT).

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. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

Wisdiag Multi-Drug Urine Home Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Marijuana, Tramadol, Fentanyl, 6-Monoacetylmorphine and Norfentanyl in human urine at the cutoff concentrations of:

Wisdiag Multi-Drug Urine Home Test Cup offers any combinations from 1 to 19 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. It is intended for over-the-counter use.

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. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

The Wisdiag Multi-Drug Urine Test Cup and Wisdiag Multi-Drug Urine Home Test Cup are rapid, single-use in vitro diagnostic devices. Each test kit contains a test device in one pouch. One pouch contains a test Wisdiag Cup and two desiccants, and a package insert. The device is in a ready-to-use format and no longer requires assembly before use.

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The Immunalysis SEFRIA™ Hydrocodone Oral Fluid Enzyme Immunoassay is an enzyme immunoassay with a cutoff of 30 ng/mL in neat oral fluid collected by Quantisal™ or Quantisal™ II Oral Fluid Collection Device. The assay is intended for the qualitative and semi-quantitative analysis of hydrocodone in human oral fluid to be used with clinical analyzers. This assay is calibrated against hydrocodone.

The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.

The Immunalysis SEFRIA™ Hydrocodone Oral Fluid Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC-MS or LC-MS/MS are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any test result, particularly when preliminary positive results are used.

The Immunalysis SEFRIA™ Hydrocodone Oral Fluid Enzyme Immunoassay is a homogenous enzyme immunoassay with a cutoff of 30 ng/mL in neat oral fluid. The assay is intended for use in laboratories with clinical chemistry analyzers for the qualitative and semi-quantitative analysis of hydrocodone in human oral fluid collected with Quantisal™ Oral Fluid Collection Device or Quantisal™ II Oral Fluid collection device.

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