Search Results

For the quantitative in vitro determination of Triglycerides in serum. Triglyceride measurements are used in the diagnosis and treatment of diseases involving lipid metabolism and various endocrine disorders e.g Diabetes mellitus, nephrosis and liver obstruction This in vitro diagnostic device is intended for prescription use only.

The Randox Triglycerides kit assay consists of ready to use reagent solutions.

The ADVIA® Chemistry Triglycerides 2 assay (TRIG 2) is intended for in vitro diagnostic use in the quantitative measurement triglycerides in human serum and plasma on the ADVIA® Chemistry systems. Measurements of triglycerides are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

The Triglyceride 2 reagent is a ready-to-use liquid reagent packaged for use on the automated ADVIA 1800 Chemistry system. It is supplied as a 358 tests/wedge. 4 wedges/Kit with a 38 mL fill in a 40 mL wedge size. Existing Siemens Set-Point Chemistry calibrator (classified under CFR 862.1150 - calibrator, multi-analyte mixture, product code JIX), cleared under 510k k030169, is used to calibrate the assay on the ADVIA Chemistry systems.

For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS® Systems. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

Not Found

The Vantera® Clinical Analyzer is an automated laboratory test analyzer which measures the 400 MHz proton nuclear magnetic resonance (NMR) spectrum of clinical samples to produce signal amplitudes, converting these signal amplitudes to analyte concentration. The device includes a 400 MHz NMR spectrometer and software to analyze digitized spectral data. This instrumentation is intended to be used with NMR based assays to detect multiple analytes from clinical samples. The NMR LipoProfile® test, when used with the Vantera® Clinical Analyzer, an automated NMR spectrometer, measures lipoprotein particles to quantify LDL particle number (LDL-P), HDL cholesterol (HDL-C), and triglycerides in human serum and plasma using nuclear magnetic resonance (NMR) spectroscopy. LDL-P and these NMR-derived concentrations of HDL-C and triglycerides are used in conjunction with other lipid measurements and clinical evaluation to aid in the management of lipoprotein disorders associated with cardiovascular disease.

The Vantera Clinical Analyzer is a clinical laboratory analyzer that employs nuclear magnetic resonance spectroscopic detection to quantify multiple analytes in biological fluid specimens, specifically blood plasma and serum. The Vantera Clinical Analyzer system design is divided into 3 major subassemblies: a sample handling assembly, an NMR subassembly, and an enclosure. The Vantera Clinical Analyzer control system is distributed across three separate computers: The Host (1U) controls user interface, data handling, results calculation, system startup and shutdown. The Process Control (4U) schedules and manages all activities required to process a sample, controls all hardware in the sample handling subsystem, and manages remote access to the system. The NMR Control Computer controls all magnet operations. Two of these computers are contained within the Sample Handling Subassembly (1U and 4U) and one in the NMR Subassembly (NMR Console). The NMR LipoProfile test involves measurement of the 400 MHz proton NMR spectrum of a plasma/serum sample, deconvolution of the composite signal at approximately 0.8 ppm to produce signal amplitudes of the lipoprotein subclasses that contribute to the composite plasma/serum signal, and conversion of these subclass signal amplitudes to lipoprotein subclass concentrations.

ELITech Clinical Systems TRIGLYCERIDES SL is intended for the quantitative in vitro diagnostic determination of triglycerides in human serum and plasma on ELITech Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. ELITech Clinical Systems CHOLESTEROL SL is intended for the quantitative in vitro diagnostic determination of cholesterol in human serum and plasma on ELITech Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the ELITech Vital Scientific Selectra/Flexor Analyzers. ELITech Clinical Systems ELITROL I & ELITROL II are multiparametric control sera for use in quality control of ELITech Clinical Systems methods on ELITech Vital Scientific Selectra/Flexor Analyzers.

The device for this submission is available as kit only. It consists of 1 reagent, "R". Reagent R contains: Pipes buffer, p-chlorophenol, ATP, Amino-4-antipyrine (4-AAP), Lipoprotein lipase (bacterial), Glycerol kinase (bacterial), Glycerol-3-phosphate oxidase (microorganisms), Peroxidase (horseradish), Potassium ferrocyanide, Magnesium (Mg2+) and Sodium azide. The device for this submission is available as kit only. It consists of 1 reagent, "R". Reagent R contains: Pipes buffer, 4-Aminoantipyrine (4-AAP), Cholesterol esterase (CHE bacterial), Cholesterol oxidase (CHO microorganisms), Peroxidase (POD horseradish), Sodium cholate, Phenol and Sodium azide. ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A. ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

System reagent for the quantitative determination of Triglyceride concentrations in human serum and plasma on OLYMPUS analyzers. Measurements of triglyceride are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various enocrine disorders, and in the assessment of risk factors for atherosclerosis and coronary artery disease.

This Olympus Triglyceride procedure is based on a series of coupled enzymatic reactions. The triglycerides in the sample are hydrolyzed by a combination of microbial lipases to give glycerol and fatty acids. The glycerol is phosphorylated by adenosine triphosphate (ATP) in the presence of glycerol kinase (GK) to produce glycerol-3-phosphate. The glycerol-3-phosphate is oxidized by molecular oxygen in the presence of GPO (glycerol phosphate oxidase) to produce hydrogen peroxide (H2O2) and dihydroxyacetone phosphate. The formed H2O2 reacts with 4-aminophenazone and N,N-bis(4-sulfobutyl)-3,5-dimethylaniline, disodium salt (MADB) in the presence of peroxidase (POD) to produce a chromophore, which is read at 660/800nm. The increase in absorbance at 660/800 nm is proportional to the triglyceride content of the sample.

The Dimension® RxL Max™ with StreamLAB® Analytical Workeell and Sample Transfer Module is a discrete photometric chemistry analyzer for clinical use intended to duplicate analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes.

The modified device includes the connection of a StreamLAB® Analytical Workcell and Sample Transfer Module. These are used to prepare specimens from the human body for testing on the Dimension® RxL Max™ system.

The Vitalab Triglycerides Reagent, the Vitalab Calibrator and the Vitalab Selectra Analyzer are intended for use as a system for the quantitative determination of triglycerides in serum and plasma. Triglycerides results may be used for the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver diseases involving lipid metabolism, various endocrine disorders, or for assessing of the risk of developing cardiovascular diseases.

The Vitalab Triglycerides Reagent, the Vitalab Calibrator and the Vitalab Selectra Analyzer are used as a system for the quantitative analysis of triglycerides in serum and plasma. The Vitalab Triglycerides Reagent determines triglycerides using the lipase/GPO enzymatic assay procedure coupled to a Trinder indicator reaction. The resulting increase in absorbance at 505 nm is proportional to the triglycerides concentration of the sample.

The CARESIDE Triglyceride cartridge is intended for in vitro diagnostic use in conjunction with the CARESIDE Analyzer to quantitatively measure the concentration of triglycerides in anti-coagulated whole blood, plasma or serum. This product is indicated for use in the diagnosis and treatment of patients with primary or secondary hyperlipidemias. Hyperlipidemias may result from liver obstruction, diseases involving lipid metabolism, or various endocrine disorders. Triglyceride results are used together by the CARESIDE Analyzer with total cholesterol and HDL-cholesterol results to calculate LDL-cholesterol levels.

CARESIDE Trighceride cartridges are used with the CARESIDE Analyzer to measure triglyceride concentration in anti-coagulated whole blood, plasma or serum specimens. The CARESIDE Triglyceride cartridge, a single use disposable in vitro diagnostic test cartridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of triglyceride concentration. The patented film cartridge contains all reagents necessary to measure triglyceride concentration. Each CARESIDE Triglyceride cartridge consists of a triglyceride-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the anticoagulated whole blood, serum, or plasma specimen into the cartridge Sample Well, closes the lid and inserts the cartridge into the CARESIDE Analyzer. Once loaded, the CARESIDE Analyzer scans the cartridge barcode, brings the cartridge and the contained specimen to 37℃, and spins the cartridge to move the sample from the sample deposition well into the cartridge channels and chambers. As the cartridge continues to spin, the blood cells are separated from the plasma/serum and the cells accumulate in the separation well. Approximately 8.5 microliters of plasma (or serum, as applicable) remain in the metering passage. Any excess sample flows into an overflow well. The plasma (or serum, as applicable) is automatically dispensed onto the multi-layer The triglyceride-containing specimen is distributed uniformly by the reagent film. spreading layer. The sample then passes through a reflection layer and into the reaction layer. Finally, the reaction mixture is pulled through the reaction layer by a suction layer where the NTB chromogen is converted into a purple formazan dye. As the cartridge spins, a photodiode measures film reflectance of light emitted from a wavelength-specific light emitting diode (LED) at a lixed time. The instrument uses the reflectance measurements and the lot-specific standard curve to calculate triglyceride concentration.