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The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-2 infection. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 infections. The HSV 1&2 ELITe MGB Assay is not FDA cleared for use with cerebrospinal fluid (CSF) specimens. The assay is not intended to be used for prenatal screening or for screening blood or blood products.

The HSV 1&2 ELITe MGB Assay is a qualitative in vitro diagnostic Real-Time PCR Assay for the direct detection of Herpes Simplex Virus (HSV) DNA (glycoprotein D gene for HSV-1 and glycoprotein G gene for HSV-2) in symptomatic male and female patients using DNA purified from swab specimens collected from individuals with cutaneous or mucocutaneous herpetic lesions. The HSV 1&2 ELITe MGB Assay system is comprised of three major processes: (1) automated preparation of unprocessed sample to extract nucleic acids from primary swab specimens using the ELITe InGenius SP 200 Extraction Cartridge, (2) PCR amplification of target DNA sequences using HSV-1 and HSV-2 specific primers, and (3) real-time detection of fluorescent-labeled HSV-1 and HSV-2 specific oligonucleotide detection probes. An Internal Control (IC), containing unrelated randomized DNA sequence, is added to all samples prior to extraction and monitors the integrity of the reagents, equipment function, and the presence of inhibitors in the samples. A positive signal in the Internal Control channel in the absence of HSV DNA indicates that the PCR has not been inhibited. The amplification reagents, Positive Control and Internal Control are packaged as part of the HSV 1&2 ELITe MGB Assay.

The Macroduct Advanced Model 3710 Sweat Collection System is intended only for clinical laboratory use by qualified medical personnel for stimulation of sweat from humans for analysis for the diagnosis of cystic fibrosis.

The Macroduct Advanced Model 3710 Sweat Collection System is intended only for clinical laboratory use by qualified medical personnel for stimulation and collection of sweat from humans for analysis for the diagnosis of cystic fibrosis. The Macroduct Advanced Sweat Collection System consists of the Macroduct Advanced Model 3710, which is a microprocessor-controlled device powered from a rechargeable lithium-ion battery, battery charging power supply and cord for charging the battery, electrode cable assembly, and a kit of single-use supplies (Pilogel discs, collectors, and straps). The system safely and efficiently accomplishes the stimulation of human sweat through pilocarpine iontophoresis using the Macroduct Advanced Model 3710. The Macroduct Advanced Sweat Collector collects a sample of the stimulated sweat. Markings on the collection tube of the collector indicate if a sufficient sweat rate is achieved during the collection of sweat. The sample can then be analyzed for indications of cystic fibrosis with the Sweat-Chek™ Sweat Conductivity Analyzer using the principle of total electrolyte concentration in the sweat sample; or with the ChloroChek® Chloridometer® using the principle of coulometric titration.

ELITech Clinical Systems BILIRUBIN TOTAL 4+1 is intended for the quantitative in vitro diagnostic determination of total bilirubin in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. ELITech Clinical Systems BILIRUBIN DIRECT 4+1 is intended for the quantitative in vitro diagnostic determination of direct bilirubin in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. It is not intended for use in Point of Care settings. Measurements of the levels of bilirubin (direct or total), an organic compound formed during the normal and abnormal distruction of red blood cells, are used in the diagnosis and treatment of liver, hematological, and metabolic disorders, including hepatitis and gall bladder block.

ELITech Clinical Systems BILIRUBIN TOTAL 4+1 and ELITech Clinical Systems BILIRUBIN DIRECT 4+1 are available as a kit only. Each kit consists of a bi-reagent R1 & R2. ELITech Clinical Systems BILIRUBIN TOTAL 4+1: Reagent 1: R1 Sulphanilic acid 29 mmol/L, Cetrimide 29 mmol/L. Reagent 2: R2 Sodium nitrite 11 mmol/L. ELITech Clinical Systems BILIRUBIN DIRECT 4+1: Reagent 1: R1 Sulphanilic acid 29 mmol/L, Reagent 2: R2 Sodium nitrite 11 mmol/L.

ELITech Clinical Systems GLUCOSE HK SL is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using ELITech Clinical Systems Selectra Pro Series Analyzers. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic diseases. 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 ELITech Clinical Systems Analyzers. ELITech Clinical Systems ELITROL II are multiparametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Analyzers.

ELITech Clinical Systems GLUCOSE HK SL is available as a kit only. It consists of a Bi-reagent R1 & R2 whose composition is: R1: Pipes buffer, pH 7.60 80 mmol/L, NAD 4.1 mmol/L, ATP 2.2 mmol/L, Sodium azide < 0.1 % R2: Hexokinase ≥ 8 500 U/L, G-6-PDH ≥ 8 500 U/L, Magnesium salt 20 mmol/L, Sodium azide < 0.1 % mmol/L. ELITech Clinical Systems ELICAL2 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 neqative for HbsAg and to the antibodies to HCV and HIV according to FDA-approved methods. ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of a 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.

ELITech Clinical Systems CALCIUM ARSENAZO is intended for the quantitative in vitro diagnostic determination of total calcium in human serum, plasma and urine using ELITech Clinical Systems Selectra Pro Series Analyzers. It is not intended for use in Point of Care settings. Calcium measurements are used in the diagnosis and treatment of parathyroid diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

ELITech Clinical Systems CALCIUM ARSENAZO is available as a kit only. It consists of a mono-reagent R whose composition is: 100 mmol/L MES buffer (pH 6.50), 200 µmol/L Arsenazo III.

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 ELITech Clinical Systems Selectra Pro Series Analyzers. ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.

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 FDAapproved 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.

ENVOY®500 CK REAGENT KIT is intended for the quantitative in vitro determination of creatine kinase (CK) in buman serum and plasma using the ENVOY 500 Chemistry System. It is not intended for use in Point of Care settings. Creatine phosphokinase and its isoenzymes measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

ENVOY CK REAGENT KIT is available as kit only. It consists of a bi-reagent R1 and R2 whose composition, for R1: 125 mmol/L Imidazole buffer, pH 6.10; 25 mmol/L D-Glucose; 25 mmol/L N-Acetyl-L-Cysteine; 12.5 mmol/L Magnesium acetate; 2.4 mmol/L NADP; 2.0 mmol/L EDTA; > 6800 U/L Hexokinase (microorganism); < 0.1% Sodium azide for R2: 250 mmol/L Creatine phosphate; 15.2 mmol/L ADP; 25 mmol/L AMP; 103 µmol/L Diadenosine pentaphosphate; ≥ 8800 U/L G-6-PDH (microorganism); < 0.1% Sodium azide.

MRSA/SA ELITe MGB® is a qualitative in vitro diagnostic test for the direct detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) using DNA purified from nasal swabs. MRSA/SA ELITe MGB® is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose, guide or monitor MRSA infections, or provide results of susceptibility to oxacillin/methicilliin. A negative result does not preclude MRSA/SA (Staphylococcus aureus) nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing. Special conditions for use statement(s): Prescription Use Only.

MRSA/SA ELITe MGB® is a real-time, multiplex polymerase chain reaction (PCR) assay for the in vitro qualitative detection of MRSA and SA DNA extracted from human nasal swab samples. In this system, sample preparation and amplification/real-time detection are completed on separate instruments. Sample processing is completed on the bioMérieux NucliSENS® easyMAG® instrument with bioMérieux NucliSENS Nucleic Acid Extraction Reagents according to the manufacturer's instructions. Following processing, the extracted sample is placed in the well of a 96 well plate to which "monoreagent" is added. The monoreagent contains the primers and probes for the genes of interest and the internal control combined with master mix. The assay is performed on an Applied Biosystems 7500 FAST Dx System that consists of the 7500 FAST Dx instrument, a personal computer, 96-well plates and seals. The total system run time is 150 minutes consisting of 60 minutes for sample processing and about 90 minutes for the real time amplification and detection steps. The instrument never comes into contact with any fluids within the 96-well plate. Each disposable plate is intended to test up to 96 samples, controls or any mixture thereof. The 96-well plates are not re-usable and are specific to the system. The kit contains enough reagents for 100 reactions. One positive and one negative control are required for each PCR run; a Negative Processing Control and a Positive Processing Control are recommended to be run in each extraction run. The design of the assay includes systems to identify both the gene responsible for methicillin resistance and for a conserved portion of a gene unique to S. aureus. Thus, for a true "MRSA," both targets will be identified in roughly equal proportions. Results are determined by using an algorithm that compares output. Cq, from the cycler (called Ct in the output from the cvcler.) The algorithm is implemented for automatic results determination by analyzing the output Cq with ELITe MGB® software.

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 ELITech Clinical Systems Selectra analyzers. ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.

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.

ELITech Clinical Systems URINE TOTAL PROTEIN Standard 100 mg/dL is intended for the calibration of quantitative ELITech Clinical Systems URINE TOTAL PROTEIN on ELITech Clinical Systems Selectra Pro Series Analyzers. ELITech Clinical Systems URINE CONTROL BI-LEVEL is a set of 2 levels of urine controls used for in vitro diagnostic in the quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.

ELITech Clinical Systems URINE TOTAL PROTEIN Standard 100 mg/dL is an aqueous solution ready to use containing bovine albumin at a concentration of 100 mg/dL and sodium azide (< 0.1 %). ELITEch Clinical Systems URINE CONTROL BI-LEVEL is a liquid solution prepared from human urine supplemented with constituents of human and animal origin, chemicals, preservatives and stabilizers. These controls are prepared exclusively from the human urine where each urine donation is tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV-1/HIV-2 according to FDA-approved methods.