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The Immunalysis Barbiturates Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 200 ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Barbiturates in human urine with automated clinical chemistry analyzers. This assay is calibrated against Secobarbital. This in vitro diagnostic device is for prescription use only. 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 Barbiturates Urine 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 is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. Immunalysis Multi-Drug Calibrators: The Immunalysis Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the following analytes: Benzoylecgonine, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam. The calibrators are designed for prescription use with immunoassays.

The Immunalysis Barbiturates Urine Enzyme Immunoassay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes a recombinant antibody to Secobarbital, a mouse monoclonal antibody to Secobarbital, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in HEPES buffer with sodium azide as a preservative. The enzyme conjugate reagent includes Barbiturates labeled with glucose-6phosphate dehydrogenase (G6PDH) in HEPES buffer with sodium azide as a preservative. Immunalysis Multi-Drug Calibrators are included as part of the test system and provided separately. The calibrator kit includes four levels of drugs and a negative calibrator in a ready-touse format. Automated clinical chemistry analyzers capable of maintaining a constant temperature, pipetting samples and reagents, mixing reagents, timing the reaction accurately and measuring enzymatic rates spectrophotometrically at 340nm can be used to perform the assay. The Immunalysis Barbiturates Urine Enzyme Immunoassay uses barbiturates recombinant and monoclonal antibody. The assay is based on the competition of Barbiturates labeled enzyme glucose-6-phosphate dehydrogenase (G6PDH) and the free drug in the urine sample for the fixed amount of antibody binding sites. In the absence of the free drug in the sample, the antibody binds the drug enzyme conjugate and enzyme activity is inhibited. This creates a dose response relationship between drug concentration in the urine and enzyme activity. The enzyme G6PDH activity is determined at 340 nm spectrophotometrically by the conversion of NAD to NADH.

The AssureTech Secobarbital Strip test is an immunochromatographic assay for the qualitative determination of Secobarbital in human urine at a Cut-Off concentration of 300ng/mL. The test may yield preliminary positive results when prescription drug Secobarbital is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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 test is intended for over-the-counter and for prescription use. The AssureTech Oxycodone Strip test is an immunochromatographic assay for the qualitative determination of Oxycodone in human urine at a Cut-Off concentration of 100ng/mL. The test may yield preliminary positive results when prescription drug Oxycodone is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Oxycodone in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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 test is intended for over-the-counter and for prescription use. The AssureTech Secobarbital/Oxycodone Panel Dip test is an immunochromatographic assay for the qualitative determination of Secobarbital and Oxycodone in human urine at a Cut-Off concentration of 300ng/mL and 100 ng/mL, respectively. The test may yield preliminary positive results when prescription drug Secobarbital or Oxycodone is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital or Oxycodone in urine. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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 test is intended for over-the-counter and for prescription use. The AssureTech Secobarbital/Oxycodone Quick Cup test is an immunochromatographic assay for the qualitative determination of Secobarbital and Oxycodone in human urine at a Cut-Off concentration of 300ng/mL and 100 ng/mL, respectively. The test may yield preliminary positive results when prescription drug Secobarbital or Oxycodone is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital or Oxycodone in urine. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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 test is intended for over-the-counter and for prescription use. The AssureTech Secobarbital/Oxycodone Turn Key-Split Cup test is an immunochromatographic assay for the qualitative determination of Secobarbital and Oxycodone in human urine at a Cut-Off concentration of 300ng/mL and 100 ng/mL. respectively. The test may yield preliminary positive results when prescription drug Secobarbital or Oxycodone is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital or Oxycodone in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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 test is intended for over-the-counter and for prescription use.

Secobarbital Strip. The AssureTech AssureTech Oxycodone Strip. AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup and AssureTech Secobarbial/Oxycodone Turn Key-Split Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Secobarbital and/or Oxycodone (target analytes) in human urine. The Quick Cup does not contain a turn-key for device activation. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

Healgen Secobarbital Test is an immunochromatographic assay for the qualitative determination of Secobarbital in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format. The test may yield preliminary positive results even when the prescription drug Secobarbital is ingescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Secobarbital in urine. 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. It is intended for prescription and for over-the-counter use. Healgen Buprenorphine Test is an immunochromatographic assay for the qualitative determination of Buprenorplaine in human urine at a Cut-Off concentration of 10 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format. The test may yield preliminary positive results even when the prescription drug Burrenorphine is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Buprenorphine in urine. 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. It is intended for prescription and for over-the-counter use. Healgen Methadone Test is an immunochromatographic assay for the qualitative determination of Methadone in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format. 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. It is intended for prescription and for over-the-counter use.

Healgen Secobarbital Test. Healgen Buprenorphine Test and Healgen Methadone Test are immunochromatographic assays for Secobarbital, Buprenorphine and Methadone. Each assay test is a lateral flow system for the qualitative detection of Secobarbital, Buprenorphine and Methadone (target analyte) in human urine. The products are in vitro diagnostic devices, which come in the form of: Strips, Cassettes, DipCards, or Cups. Each product contains a Test Device (in one of the four formats), and a package insert. Each test device is sealed with a desiccant in an aluminum pouch.

CR3 Keyless Split Sample Cup Secobarbital-Methadone is a rapid test for the qualitative detection of Secobarbital and Methadone in human urine at a cutoff concentration of 300ng/mL for each of the drugs. The test may yield preliminary positive results when prescription drugs Secobarbital and Methadone are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital and Methadone in urine. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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 CR3 Keyless Split Sample Cup Secobarbital - Methadone test uses immunochromatographic assays for secobarbital and methadone. The test is a lateral flow system for the qualitative detection of secobarbital and methadone in human urine. The test is the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

The Snap-Top Split Key Cup for use with the GenPrime Drugs of Abuse (DOA) Reader System is for in vitro diagnostic use and is intended for prescription use in laboratories, point-of-care and workplaces by trained users. The test is not intended for over-the-counter use. The test cannot be read visually and must be used with the GenPrime DOA Reader. The Snap-Top Split Key Cup qualitatively detects drug classes in human urine at the cutoff concentrations shown below: - Test/ Calibrated to /Cutoff Amphetamines/ d-Amphetamine/ 500 ng/mL Barbiturates/ Secobarbital/ 300 ng/mL Benzodiazepines/ Oxazapam/ 300 ng/mL Cocaine/ Benzoylecgonine/ 150 ng/mL Methamphetamine/ d-Methamphetamine/ 500 ng/mL Methadone/ Methadone/ 300 ng/mL Morphine/ Morphine/ 300 ng/mL Morphine 2000/ Morphine/ 2000 ng/mL Oxycodone/ Oxycodone/ 100 ng/mL Phencyclidine/ Phencyclidine/ 25 ng/mL Marijuana/ Delta-9-THC-COOH/ 50 ng/mL Configurations of the Snap-Top Split Key Cup may consist of any combination of the above listed drug analytes. The Snap-Top Split Key Cup provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography / mass spectrometry (GC/MS), high performance liquid chromatography (HPLC) or liquid chromatography/tandem mass spectrometry (LC/MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

The GenPrime Drugs of Abuse (DOA) Reader System consists of a small, portable high resolution flatbed scanner, customized GenPrime DOA Reader Software, and lateral flow tests that are intended for use in the system. The scanner has a custom Scanner Lid with an opening for the test device, and a Scanner Stand, which places the scanner bed at the appropriate angle for running and reading the test devices. The System is intended for use with the Snap-Top Split Key Cup, which is a rapid, single use, disposable immunochromatographic test for the qualitative detection of drugs of abuse in human urine (K130082). This description is limited to the Snap-Top Split Key Cup (SK Cup), with 3 additional drugs being added, giving 11 total drugs. The Snap-Top SK cup contains up to five (5) test strips embedded in a urine sample cup, containing a total of up to 11 drug test lines (between one and four drug test lines per test strip). Different drug configurations may be used. Each test strip has an internal control line to confirm validity of the test results. The Snap-Top SK Cup Drugs of Abuse Test devices are run in the GenPrime DOA Reader System according to their specific instructions for use. At the conclusion of the test (5 minutes) an image is captured and the software algorithm determines whether the colored test lines for each analyte are above or below the threshold associated with a negative or positive result. The software also confirms the validity of the results by verifying the presence of control lines. The results are recorded and logged into a database along with an image of the test, patient and operator information and the time of image capture. The results can be viewed, printed, or sent to a recipient via email or other electronic method. The GenPrime DOA Reader is for in vitro diagnostic use and is intended for use in laboratories, point-of-care sites and workplaces by trained users. The test is not intended for over-the-counter use. The GenPrime DOA Reader System test devices cannot be read visually. All analytes on the Snap-Top SK Cup for use with the GenPrime DOA Reader System were previously cleared (K130082) except for the drug tests for benzodiazepines, cocaine and barbiturates.

One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are lateral flow chromatographic immunoassay designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations: | Test | Calibrator | Cut-off level | |------------------------------------------|---------------------------------------|---------------| | Barbiturates (BAR) | Secobarbital | 300 ng/mL | | Benzodiazepines (BZO) | Oxazepam | 300 ng/mL | | Methylenedioxymethampheta<br>mine (MDMA) | 3,4-Methylenedioxymetha<br>mphetamine | 500 ng/mL | | Methadone (MTD) | Methadone | 300 ng/mL | | Oxycodone (OXY) | Oxycodone | 100 ng/mL | | Phencyclidine (PCP) | Phencyclidine | 25 ng/mL | The tests contain two formats:1) Test Cup, 2) Test Dipcard, The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use. They are intended for prescription use in clinical laboratories only and not for point-of-care use. This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Barbiturates, Benzodiazepines, Methylenedioxymethamine, Methadone, Oxycodone, Phencyclidine and their metabolites at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument.

The Randox Laboratorles Ltd. barbiturates Assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of barbiturates in human urine on the Rx Imola and Rx Daytona. The cutoff for secobarbital is 200 ng/mL. This in vitro diagnostic device Is intended for prescription use only. The semi-quantitative mode is for purpose of - (1) enabling laboratories to determine an appropriate dilution of the specimen for - confirmation by a confirmatory method such as GCMS. - Or - .. .. . ... . . . . . . (2) permilting laboratories to establish quality control procedures ... ... . . . . . . This 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 chromatograph/mass spectrometry (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 Randox Multidrug Calibrator Set consists of liquid calibrators containing Secobarbital, Oxazepam and Methadone. There are 5 levels of calibrator. They have been developed for use in the calibration of Barbiturates, Benzodiazepines and Methadone assays for use on the JSC and analysers, which includes the a y to na" and the moss™. This in vitro diagnostic device is intended for prescription use only. The Randox Multidrug Controls level 1 and 2 are liquid controls containing Secobarbital, Oxazepam and Methadone. There are 2 levels of controls. They have been developed for use in the quality control of Barbiturates, Benzodiazepines and Methadone assays for use on the I Kommanalysers, which includes the X day to na™ and the Anmone™. This in vitro diagnostic device is intended for prescription use only.

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The UCP Drug Screening Test Cups are rapid, qualitative, competitive binding immunoassays for the detection the following drugs and their metabolites in human urine: | Test | Calibrator | Cut-off | |--------------------------|-------------------|------------| | Amphetamine | D-Amphetamine | 1000 ng/mL | | Barbiturates | Secobarbital | 300 ng/mL | | Benzodiazepines | Oxazepam | 300 ng/mL | | Cocaine | Benzoylecgonine | 300 ng/mL | | Marijuana | Delta-9-THC-COOH | 50 ng/mL | | Methadone | Methadone | 300 ng/mL | | Methamphetamine | D-Methamphetamine | 1000 ng/mL | | MDMA | MDMA | 500 ng/mL | | Morphine | Morphine | 300 ng/mL | | Opiate 2000 | Morphine | 2000 ng/mL | | Oxycodone | Oxycodone | 100 ng/mL | | Phencyclidine | Phencylidine | 25 ng/mL | | Tricyclic Antidepressant | Nortriptyline | 1000 ng/mL | The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for over-the-counter (OTC) users as the first step in a two step process to provide consumers, including but not limited to concerned parents, 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, along with the materials for shipping the urine specimen to the laboratory, is provided. The test is also intended for health care professional users. The tests will yield preliminary positive results when the prescription drugs Barbiturates, Oxycodone, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Oxycodone, Tricyclic Antidepressant in urine. The tests only provide a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method for most drugs (HPLC is the preferred confirmatory method for Tri-cyclic Antidepressants). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.

The UCP Drug Screening Test Cups are rapid, qualitative, competitive binding immunoassays for the detection the following drugs and their metabolites in human urine: | Test | Calibrator | Cut-off | |--------------------------|-------------------|------------| | Amphetamine | D-Amphetamine | 1000 ng/mL | | Barbiturates | Secobarbital | 300 ng/mL | | Benzodiazepines | Oxazepam | 300 ng/mL | | Cocaine | Benzoylecgonine | 300 ng/mL | | Marijuana | Delta-9-THC-COOH | 50 ng/mL | | Methadone | Methadone | 300 ng/mL | | Methamphetamine | D-Methamphetamine | 1000 ng/mL | | MDMA | MDMA | 500 ng/mL | | Morphine | Morphine | 300 ng/mL | | Opiate 2000 | Morphine | 2000 ng/mL | | Oxycodone | Oxycodone | 100 ng/mL | | Phencyclidine | Phencylidine | 25 ng/mL | | Tricyclic Antidepressant | Nortriptyline | 1000 ng/mL | The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for over-the-counter (OTC) users as the first step in a two step process to provide consumers, including but not limited to concerned parents, 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, along with the materials for shipping the urine specimen to the laboratory, is provided. The test is also intended for health care professional users. The tests will yield preliminary positive results when the prescription drugs Barbiturates, Oxycodone, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Oxycodone, Tricyclic Antidepressant in urine. The tests only provide a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method for most drugs (HPLC is the preferred confirmatory method for Tri-cyclic Antidepressants). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.

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