Search Results

The Chromsystems MassCheck Immunosuppressant Whole Blood Controls are in vitro diagnostic devices intended to verify performance of various laboratory assay systems that measure cyclosporine, tacrolimus, or sirolimus.

The Chromsystems MassCheck Immunosuppressant Controls are Ivophilized, multi-analyte human whole blood based products containing the analytes Ciclosporin A, Rapamycin (Sirolimus) and Tacrolimus. The Controls are available as four levels + blank. Prior to use the different lyophilized controls need to be reconstituted by adding the corresponding amount of water as indicated on the respective packing leaflet. Each donor was tested and found negative for Human immunodeficiency virus (HIV) 1 and 2, Hepatitis B virus (HBV), Hepatitis C virus (HCV) in European blood banks. The tests used were cleared for in vitro diagnostic use in the EU (in compliance with the European Directive 98/79/EC on in vitro Diagnostic Medical Devices as Annex II, List A products) and are also approved by the Paul-Ehrlich-Institute in Germany.

The Quantimetrix Corp. NiCosure Cotinine Urine Control is intended as a means of monitoring the performance of GC/MS and other drugs of Cotinine methods used for detecting the Cotinine levels in unknown urine specimens. Use of quality control materials is an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method.

Not Found

The MAS Immunosuppressant Controls, consisting of levels 1 through 3, are in-vitro diagnostic medical devices intended for use as assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine, sirolimus, and tacrolimus.

MAS Immunosuppressant Controls is prepared from human whole blood, with pure chemicals and stabilizers. The control is provided in a liquid form containing Cyclosporine, Sirolimus, and Tacrolimus.

The DRI® Oxycodone Assay is intended for the qualitative and semi-quantitative detection of oxycodone in human urine. 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) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. The DRI® Oxycodone Assay is intended to be used for the qualitative and semiquantitative determination of the presence of oxycodone in human urine at cutoffs of 100 and 300 ng/mL. The assay provides a simple and rapid analytical screening procedure to detect oxycodone in human urine. The DRI® Oxycodone Calibrators are used to calibrate the DRI® Oxycodone Assay in human urine. The DRI® Oxycodone Controls are used to qualify the DRI® Oxycodone Assay in human urine.

The DRI® Oxycodone Assay is supplied as liquid ready-to-use homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect oxycodone and oxymonthone without significant cross-reactivity to other opiate compounds. The assay is based on computition between oxycodone labeled with glucose-6-phosphate dehydrogenase (G6PDH), and oxycodone present in the urine sample for a fixed amount of specific antibody binding and a necess. In the absence of free oxycodone in the sample, the specific antibody binds the drug labeled with G6PDH and causes a decrease in enzyme activity. This phenomenon creates a direct relationship between the drug concentration in urine and enzyme activity. The enzyme activity is deternined spectrophotometrically at 340 nm by measuring the conversion of nicotinamide adenine dinucleotide (NAD) to NADH.

The Microgenics Cyclosporine Controls, consisting of levels 1 through 5, are in-vitro diagnostic medical devices intended for use as assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine.

The Microgenics Cyclosporine Controls are prepared from whole human blood, with pure chemicals stabilizers added. The control kit includes five separate controls known as C1, C2, C3, C4 and C5 with target concentrations of approximately 70, 200, 350, 700 and 1600 ng cyclosporine/mL. The Microgenics Cyclosporine Controls are provided in lyophilized form for increased stability.

The CEDIA® Cyclosporine Plus High Range Controls 4 and 5 are in-vitro diagnostic medical devices intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine.

Not Found

Reference Material for Delta-9-THC-COOH in Human Urine is a material intended for use in verifying the accuracy of GC/MS methods used for quantitation of this analyte in human urine.

Reference Material for Delta-9-THC-COOH in Human Urine

The INNOFLUOR™ Topinamate Assay System is a fluorescence polarization immunoassay intended for the quantitative determination of total topiramate in serum or heparinized plaama for therapeutic drug monitoring. The assay system is for use on the Abbott TDxf or the TDxFLX® analyzer.

The INNOFLUOR™ Topiramate Assay System is a fluorescence polarization immunoassay intended for the quantitative determination of total topiramate in serum or heparinized plaama for therapeutic drug monitoring. The assay system is for use on the Abbott TDxf or the TDxFLX® analyzer.

The SYNCHRON Systems 10 ng/mL and 40 ng/mL THC Urine Controls, in conjunction with the SYNCHRON Cannabinoid 20 ng (THC2) Reagent, are intended for use on SYNCHRON Systems for monitoring the quality control of cannabinoid (THC) testing in the clinical laboratory. These controls are designed for use with the family of SYNCHRON Systems which include analyzers such as the SYNCHRON CX4, CX®4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, CX7 DELTA Systems and LX™20 Systems.

The SYNCHRON® Systems 10 ng/mL and 40ng/mL THC Urine Controls, are ready-to-use, human urine based liquid controls designed to be used as part of a laboratory total quality management program to ensure proper THC assay performance. These controls complement the current panel of Cannabinoid reagents and controls previously cleared by the FDA. The kit consists of 1 x 5.0 mL bottle and must be stored at +2°C to + 8°C.