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Abuscreen ONLINE for Barbiturates is an in vitro diagnostic test for the qualitative and semiquantitative detection of barbiturates in human urine on the Hitachi 917 analyzer at a cutoff of 200 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of barbiturate use or abuse.

Abuscreen ONLINE Barbiturates is an in vitro diagnostic test for the qualitative and semiquantitative detection of barbiturates in human urine on automated clinical chemistry analyzers at a cutoff of 200 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of barbiturate use or abuse. The proposed Abuscreen ONLINE Barbiturates test kit is specifically intended for use on the Hitachi 917 Analyzer and future similar analyzer models. It was adapted from the currently marketed Abuscreen ONLINE Barbiturates test kit. The labeling and packaging have been modified for use on the Hitachi 917 Analyzer as well as a modification to the buffer formulation and the addition of a surfactant to the diluent. This modified test kit is not a replacement to the currently marketed kit. The Hitachi 917 Analyzer System is a fully automatic, computer-controlled system for clinical chemistry. It was conceived for both quantitative and qualitative in vitro determination using a large variety of tests for analysis, e.g. in serum and urine. Integrated in the system is an ion-selective unit for determination of electrolytes. The throughput per hour is 800 tests for clinical chemistry (1200 with electrolytes). The system consists of the analyzer which performs all functions required for fully automatic sample and test processing. Beginning with the automatic recording of patient samples - provided that they are supplied in barcode-labeled vessels - up to the photometric measurement and results transmission to the computer unit.

Abuscreen ONLINE Benzodiazepines is an in vitro diagnostic test for the qualitative and semiquantitative detection of benzodiazepines in human urine on the Hitachi 917 analyzer at cutoff concentrations of 100 ng/mL, 200 ng/mL, and 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of benzodiazepine use or abuse.

The proposed Abuscreen ONLINE Benzodiazepines test kit is specifically intended for use on the Hitachi 917 Analyzer and future similar analyzer models. It was adapted from the currently marketed Abuscreen ONLINE Benzodiazepines test kit. The labeling and packaging have been changed for use on the Hitachi 917 Analyzer as well as an addition of a surfactant to the diluent. This modified test kit is not a replacement to the currently marketed kit. The Hitachi 917 Analyzer System is a fully automatic, computer-controlled system for clinical chemistry. It was conceived for both quantitative and qualitative in vitro determination using a large variety of tests for analysis, e.g. in serum and urine. Integrated in the system is an ion-selective unit for determination of electrolytes. The throughput per hour is 800 tests for clinical chemistry (1200 with electrolytes). The system consists of the analyzer which performs all functions required for fully automatic sample and test processing. Beginning with the automatic recording of patient samples - provided that they are supplied in barcode-labeled vessels - up to the photometric measurement and results transmission to the computer unit.

Abuscreen ONLINE for Phencyclidine is an in vitro diagnostic test for the qualitative and semiquantitative detection of phencyclidine and its metabolites in human urine on the Hitachi 917 analyzer at a cutoff concentration of 25 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of phencyclidine use or abuse.

Abuscreen ONLINE for Phencyclidine is an in vitro diagnostic test for the qualitative and semiquantitative detection of phencyclidine and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff concentration of 25 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of phencyclidine use or abuse. The proposed Abuscreen ONLINE Phencyclidine test kit is specifically intended for use on the Hitachi 917 Analyzer and future similar analyzer models. It was adapted from the currently marketed Abuscreen ONLINE Phencyclidine test kit. The labeling and packaging have been changed for use on the Hitachi 917 Analyzer as well as an addition of a surfactant to the diluent. This modified test kit is not a replacement to the currently marketed kit. The Hitachi 917 Analyzer System is a fully automatic, computer-controlled system for clinical chemistry. It was conceived for both quantitative and qualitative in vitro determination using a large variety of tests for analysis, e.g. in serum and urine. Integrated in the system is an ion-selective unit for determination of electrolytes. The throughput per hour is 800 tests for clinical chemistry (1200 with electrolytes). The system consists of the analyzer which performs all functions required for fully automatic sample and testprocessing. Beginning with the automatic recording of patient samples - provided that they are supplied in barcode-labeled vessels - up to the photometric measurement and results transmission to the computer unit.

Abuscreen ONLINE BENZ 200 Calibrators are designed for the calibration of the Roche assays for Benzodiazepines. This clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

Abuscreen ONLINE BENZ 200 Calibrators are designed for the calibration of the Roche assays for Benzodiazepines. This clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. The matrix is urine and the levels of Benzodiazepines (ng/mL) are 0, 100, 200, 400.

Abuscreen ONLINE BENZ 300 Calibrators are designed for the calibration of the Roche assays for Benzodiazepines. This clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

Abuscreen ONLINE BENZ 300 Calibrators are designed for the calibration of the Roche assays for Benzodiazepines. This clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the measurement of substances in human specimens.

Abuscreen ONLINE Cocaine Metabolite is an in vitro diagnostic test for the qualitative and semiquantitative detection of benzoylecgonine, the primary metabolite of cocaine in human urine on automated clinical chemistry analyzers at a cutoff concentrations of 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of cocaine use or abuse.

Abuscreen ONLINE Cocaine Metabolite is an in vitro diagnostic test for the qualitative and semiquantitative detection of benzoylecgonine, the primary metabolite of cocaine in human urine on automated clinical chemistry analyzers at a cutoff concentrations of 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of cocaine use or abuse. The proposed Abuscreen ONLINE Cocaine Metabolite test kit is specifically intended for use on the Hitachi 917 Analyzer and future similar analyzer models. It was adapted from the currently marketed Abuscreen ONLINE Cocaine Metabolite test kit. The reagent compositions are the same as the previously cleared Abuscreen ONLINE Cocaine Metabolite kit; although the labeling and packaging have been modified for use on the Hitachi 917 Analyzer. This modified test kit is not a replacement to the currently marketed kit. The Hitachi 917 Analyzer System is a fully automatic, computer-controlled system for clinical chemistry. It was conceived for both quantitative and qualitative in vitro determination using a large variety of tests for analysis, e.g. in serum and urine. Integrated in the system is an ion-selective unit for determination of electrolytes. The throughput per hour is 800 tests for clinical chemistry (1200 with electrolytes). The system consists of the analyzer which performs all functions required for fully automatic sample and test processing. Beginning with the automatic recording of patient samples - provided that they are supplied in barcode-labeled vessels - up to the photometric measurement and results transmission to the computer unit.

Abuscreen ONLINE for Amphetamines is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamine and methamphetamine and their metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 1000 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of amphetamine use or abuse.

Abuscreen ONLINE Amphetamines is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamine and methamphetamine and their metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 1000 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of amphetamine use or abuse. The proposed Abuscreen ONLINE Amphetamines test kit is specifically intended for use on the Hitachi 917 Analyzer and future similar analyzer models. It was adapted from the currently marketed Abuscreen ONLINE Amphetamines test kit. The reagent compositions are the same as the previously cleared Abuscreen ONLINE Amphetamines kit; although the labeling and packaging have been modified for use on the Hitachi 917 Analyzer. This modified test kit is not a replacement to the currently marketed kit. The Hitachi 917 Analyzer System is a fully automatic, computer-controlled system for clinical chemistry. It was conceived for both quantitative and qualitative in vitro determination using a large variety of tests for analysis, e.g. in serum and urine. Integrated in the system is an ion-selective unit for determination of electrolytes. The throughput per hour is 800 tests for clinical chemistry (1200 with electrolytes). The system consists of the analyzer which performs all functions required for fully automatic sample and test processing. Beginning with the automatic recording of patient samples - provided that they are supplied in barcode-labeled vessels - up to the photometric measurement and results transmission to the computer unit.

Abuscreen ONLINE for Propoxyphene is an in vitro diagnostic test for the qualitative and semiquantitative detection of propoxyphene and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff concentration of 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of propoxyphene use or abuse.

The proposed Abuscreen ONLINE Propoxyphene test kit is specifically intended for use on the Hitachi 917 Analyzer and future similar analyzer models. It was adapted from the currently marketed Abuscreen ONLINE Propoxyphene test kit. The labeling and packaging have been changed for use on the Hitachi 917 Analyzer as well as an addition of a surfactant to the diluent. This modified test kit is not a replacement to the currently marketed kit. The Hitachi 917 Analyzer System is a fully automatic, computer-controlled system for clinical chemistry. It was conceived for both quantitative and qualitative in vitro determination using a large variety of tests for analysis, e.g. in serum and urine. Integrated in the system is an ion-selective unit for determination of electrolytes. The throughput per hour is 800 tests for clinical chemistry (1200 with electrolytes). The system consists of the analyzer which performs all functions required for fully automatic sample and test processing. Beginning with the automatic recording of patient samples - provided that they are supplied in barcode-labeled vessels - up to the photometric measurement and results transmission to the computer unit.

Abuscreen ONLINE for Cannabinoids is an in vitro diagnostic test for the qualitative and semiquantitative detection of cannabinoids in human urine on automated clinical chemistry analyzers at cutoff concentrations of 20 ng/mL, 50 ng/mL, and 100 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of cannabinoid use or abuse.

Abuscreen ONLINE Cannabinoids is an in vitro diagnostic test for the qualitative and semiquantitative detection of cannabinoids and its metabolites in human urine on automated clinical chemistry analyzers at cutoff concentrations of 20 ng/mL, 50 ng/mL, and 100 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of cannabinoid use or abuse. The proposed Abuscreen ONLINE Cannabinoids test kit is specifically intended for use on the Hitachi 917 Analyzer and future similar analyzer models. It was adapted from the currently marketed Abuscreen ONLINE Cannabinoids test kit. The labeling and packaging have been changed for use on the Hitachi 917 Analyzer as well as an addition of a surfactant to the diluent. This modified test kit is not a replacement to the currently marketed kit. The Hitachi 917 Analyzer System is a fully automatic, computer-controlled system for clinical chemistry. It was conceived for both quantitative and qualitative in vitro determination using a large variety of tests for analysis, e.g. in serum and urine. Integrated in the system is an ion-selective unit for determination of electrolytes. The throughout per hour is 800 tests for clinical chemistry (1200 with electrolytes). The system consists of the analyzer which performs all functions required for fully automatic sample and test processing. Beginning with the automatic recording of patient samples - provided that they are supplied in barcode-labeled vessels - up to the photometric measurement and results transmission to the computer unit.

Abuscreen ONLINE Methadone is an in vitro diagnostic test for the qualitative and semiquantitative detection of methadone in human urine on automated clinical chemistry analyzers at a cutoff concentration of 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of methadone use or abuse.

Abuscreen ONLINE Methadone is an in vitro diagnostic test for the qualitative and semiquantitative detection of methadone in human urine on automated clinical chemistry analyzers at a cutoff concentration of 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of methadone use or abuse. The proposed Abuscreen ONLINE Methadone test kit is specifically intended for use on the Hitachi 917 Analyzer and future similar analyzer models. It was adapted from the currently marketed Abuscreen ONLINE Methadone test kit. The labeling and packaging have been changed for use on the Hitachi 917 Analyzer as well as an addition of a surfactant to the diluent. This modified test kit is not a replacement to the currently marketed kit. The Hitachi 917 Analyzer System is a fully automatic, computer-controlled system for clinical chemistry. It was conceived for both quantitative and qualitative in vitro determination using a large variety of tests for analysis, e.g. in serum and urine. Integrated in the system is an ion-selective unit for determination of electrolytes. The throughput per hour is 800 tests for clinical chemistry (1200 with electrolytes). The system consists of the analyzer which performs all functions required for fully automatic sample and test processing. Beginning with the automatic recording of patient samples - provided that they are supplied in barcode-labeled vessels - up to the photometric measurement and results transmission to the computer unit.