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The BD FACS™ Sample Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto™ II and BD FACSCalibur™ flow cytometry systems. Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCanto™ II flow cytometry systems: - BD Multitest 6-Color TBNK Reagent with or without BD Trucount Tubes . - BD Multitest IMK Kit with or without BD Trucount Tubes . - BD Multitest CD3 FITC/CD16+CD56 PE/CD45 PerCP/CD19 APC with or . without BD Trucount Tubes - BD Multitest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC with or without BD . Trucount Tubes Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCalibur™ flow cytometry systems: - BD Multitest IMK Kit with or without BD Trucount Tubes . - BD Multitest CD3 FITC/CD16+CD56 PE/CD45 PerCP/CD19 APC with or . without BD Trucount Tubes - BD Multitest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC with or without BD . Trucount Tubes - BD Tritest CD3/CD16+56/CD45 with or without BD Trucount Tubes . - BD Tritest CD3/CD19/CD45 with or without BD Trucount Tubes . - BD Tritest CD3/CD4/CD45 with or without BD Trucount Tubes . - BD Tritest CD3/CD8/CD45 with or without Trucount Tubes . - BD Tritest CD4/CD8/CD3 with BD Trucount Tubes . For in vitro diagnostic use.

The BD FACS™ Sample Prep Assistant III (SPA III) is a microprocessorcontrolled pipetting and diluting system which automatically prepares whole blood samples using the lyse / no-wash sample preparation method for flow cytometry. Used as an accessory to the BD FACSCalibur flow cytometer, the SPA III combines fluidic, optic, robotic, and electronic components to automatically prepare samples for acquisition and analysis. The SPA III pierces the sample tube cap to withdraw sample, aliquots blood and reagent into daughter tubes, and mixes the sample according to preprogrammed or custom protocols. The device also adds lysing solution and automates cleaning procedures. The unit consists of an enclosure, one robotic pipetting module moving in the X/Y/Z axes, a power supply, a central controller unit, fluid pumps, and a barcode reader.

COULTER TQ-Prep Workstation: Intended to prepare leukocytes from whole blood for In Vitro Diagnostic (IVD) Use when used with the COULTER ImmunoPrep Reagent System and cleared Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers. Indication for Use: Pipetting of ImmunoPrep Reagent System (lyse, stabilizer, and fixative reagents) to samples prepared either manually or with the COULTER PrepPlus 2 sample preparation device to achieve lysis of whole blood samples. Use of COULTER TQ-Prep with cleared Beckman Coulter flow cytometers is described in each application's Instructions for Use. For In Vitro Diagnostic Use Only. COULTER PrepPlus 2: Intended Use: The COULTER PrepPlus 2, when used in combinations with the COULTER TQ-Prep Workstation, is intended to prepare human whole blood for In Vitro Diagnostic (IVD) Use with cleared Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers. Indications for Use: Pipetting blood, cleared Beckman Coulter IVD reagents and Flow-Count Fluorospheres to prepare samples for flow cytometric analysis. Use of the PrepPlus 2 with cleared Beckman Coulter flow cytometers is described in each application Instructions for Use. For In Vitro Diagnostic Use Only.

The COULTER TO-Prep Workstation is used with the COULTER ImmunoPrep Reagent System to prepare leukocytes from whole blood for measurement on flow cytometers. The COULTER PrepPlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.

The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry. This is the same intended use as previously cleared for the BD FACSCanto system with BD FACSCanto clinical software. Indications for Use: - Immunophenotyping in clinical laboratories, using previously cleared IVD I assays for flow cytometry that utilize the lyse no-wash sample preparation method. - Immunophenotyping of lymphocyte subsets including CD3*CD8*, CD3*CD4*, CD3 CD16* and/or CD56*, CD3 CD19*, and CD3*. - For in vitro diagnostic use. - For use with or without the BD FACS Sample Prep Assistant II.

The BD FACSCanto system with BD FACSCanto clinical software is a flow cytometry system designed for analyzing samples prepared with the lyse / no-wash method. The BD FACS Sample Prep Assistant II is a microprocessor-controlled pipetting and diluting system which automatically prepares whole blood samples using the lyse / no-wash sample preparation method for flow cytometry. Used as an accessory to the BD FACSCanto flow cytometer, the SPA II combines fluidic, optic, robotic, and electronic components to automatically prepare samples for acquisition and analysis with a flow cytometer. The SPA II pierces the sample tube cap to withdraw sample, aliquots blood and reagent into daughter tubes, and mixes the sample according to preprogrammed or custom protocols. The device also adds lysing solution and automates cleaning protocols. The unit consists of an enclosure, one robotic pipetting module moving in the X/Y/Z axes, a power supply, a central controller unit, fluid pumps, and a barcode reader.

The BD Viper"™ instrument is intended for use as a sample processor designed for use with the BD ProbeTec ™ ET system and the BD ProbeTec ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) assays. The BD Viper instrument automates the transfer and mixing of manually prepared and lysed samples. The BD Viper instrument incorporates heating blocks to perform assay priming and prewarming incubation steps prior to the removal and transfer of the microwells to the BD ProbeTec ET instrument for amplification and detection.

The BD Viper is a sample processor designed for use with the BD ProbeTec ET system. The BD Viper automates the transfer and mixing of specimens that have been prepared and lysed according to the specific BD ProbeTec ET assay package insert. Automated specimen transfers by the BD Viper occur from the sample processing tubes to the assay priming microwells and from the priming microwells to the assay amplification microwells. The BD Viper also controls the incubation steps for priming the samples and pre-warming the amplification microwells. After the BD Viper transfers samples from the priming wells to the amplification microwells, the instrument mixes the contents of the amplification microwells. After mixing, the plates are manually sealed and removed from the BD Viper. The sealed plates are placed into the BD ProbeTec ET instrument(s) where the analyte specific amplification and detection process occurs. The BD Viper is comprised of four major components: robotic pipetting arm, priming and warming heaters, LCD monitor with integrated touch screen, and instrument software.

MasterCAP AM 5.0 is a software tool for Assay Management designed to support the set up of an in vitro diagnostic assay run. It is designed to be used with Pharmacia CAP System diagnostic equipment and related devices. It is run either in Microsoft Windows, 3.x, or Windows '95 Environment. MasterCAP AM 5.0 handles sample lists, and creates worklists for the related Pharmacia & Upjohn diagnostic equipment. MasterCAP AM 5.0 also evaluates and calculates the assay results and generates laboratory reports. It can import and export results to main frame computers. MasterCAP AM 5.0 includes a driver function which can send and receive patient data from UniCAP 100 diagnostic equipment. MasterCAP RM 5,0 is a software tool for Request Management designed to be used together with MasterCAP AM 5.0. MasterCAP RM 5.0 includes a database and provides features for request management and data storage. MasterCAP RM handles requests and creates sample lists to be used in MasterCAP AM. When the data are evaluated, MasterCAP RM collects the results and generates a result report for each request. MasterCAP RM can store requests, requestor information and test panels, and also provides backup and restore functions.

1. MasterCAP AM 5.0 is a software tool for assay management designed to support the set up of an in vitro diagnostic immunoassay. It is designed to be used with Pharmacia CAP System diagnostic equipment and related devices. It is run either in Microsoft Windows, 3.x or Windows '95 Environment. The following Pharmacia CAP System diagnostic equipment and related devices may be used with MasterCAP AM: AutoCAP, Positioning Guide 96, RoboCAP Version 2.0, Fluorocount 96, Assay Washer 96, UniCAP 100. When using the UniCAP 100 Device Driver Function of MasterCAP AM with UniCAP 100, you can transfer sample list data to, and import evaluated assay results from, one or more connected UniCAP 100 devices. MasterCAP AM 5.0 software directs the diagnostic equipment to perform the following functions: * import sample lists from a main frame computer or enter the information manually - * create an assay run - * distribute samples and tests - * process an assay - * collect raw data - * evaluate and calculate the results - * export the results to the main frame computer - * define assay methods and method groups 2. MasterCAP RM 5.Q is a software tool for Request Management designed to be used with MasterCAP AM 5.0 for laboratories running in vitro diagnostic assays. MasterCAP RM includes a database and provides features for request management and data storage. MasterCAP RM handles requests and creates sample lists to be used in MasterCAP AM. When the data are evaluated, MasterCAP RM collects the results and generates a result report for each request. MasterCAP AM and MasterCAP RM are designed to be used with Pharmacia CAP System and UniCAP 100 diagnostic equipment and related devices. MasterCAP RM can perform the following functions: - * create sample lists - * store requests, requester information and test panels - * create laboratory, result and patient test reports - * perform database queries - * provide backup and restore functions

The COBAS AMPLICOR Analyzer is an in vitro diagnostic device intended for use in clinical laboratories for the automation of the AMPLICOR™ Polymerase Chain Reaction test procedures.

The COBAS AMPLICOR is a flexible, automated bench top batch analyzer that automates the amplification and detection steps of the Polymerase Chain Reaction (PCR) process. The COBAS AMPLICOR combines the operations of automated sample handling, reagents deliver, thermal cycling, controlled temperature incubation, photometric detection and result reporting into a single automated analyzer. The instrument consists of five major sub-components: (1) a thermal cycler module; (2) an automated pipeting station; (3) an incubation station; (4) a wash station; and (5) a photometer. An internal computer controls and monitors the major components includingsystem and run control, input/output, communication, results calculaton, and system diagnostic tests.

UniCAP Specific IgE Assay is an in vitro semi-quantitative assay for the 1. measurement of allergen specific IgE in human serum or plasma. UniCAP Specific IgE assay is to be used with the instrument UniCAP 100. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other findings, and is to be used in clinical laboratories, as well as, physician office laboratories. 2. UniCAP 100 is a fully integrated and automated instrument including software for immunodiagnostic testing. UniCAP 100 is a user friendly instrument designed to handle all steps from sample and reagent handling to processing of results. 3. UniCAP 100 RM External Software is intended to be used with a Windows-based PC operating up to five UniCAP 100 instruments. The external software creates requests and assay runs, retrieves the test results from the instrument, and prints reports. It can also import requests from, and export requests to. a connected mainframe computer or network server. 4. Pharmacia Specific IgE Control is intended for laboratory use in monitoring the performance of specific IgE measurements as determined by UniCAP™ Specific IgE and Pharmacia CAP System™ RAST® RIA/FEIA. 5. Pharmacia Specific IgE Negative Control is intended for laboratory use in monitoring the performance of specific IgE measurements as determined by UniCAP™ Specific IgE, Pharmacia CAP System™, RAST® RIA/FEIA and Phadebas RAST® RIA/FEIA and Phadebas RAST®/Phadezym®.

UniCAP is a fully integrated and automated system for the determinantion of specific IgE in human blood serum or plasma. The UniCAP system includes the UniCAP 100 instrument with software for immunodiagnostic testing; UniCAP reagents, in this submission reagents for the measurement of allergen specific IgE; UniCAP RM External Software; and Pharmacia Specific IgE positive and negative Controls. The UniCAP 100 instrument is designed to handle all steps from sample and reagent handling to processing of results. Reagents, requests, samples and ImmunoCAP are loaded into the instrument and the process, which takes 2.5 hours is started. A laboratory report is automatically printed when the process is ended. UniCAP 100 can store a calibration curve to be used for up to one month. After an initial calibration curve is accepted by the software, subsequent assay runs may use the stored calibration curve for calculation of results. In these runs, Curve Controls are included to validate that the run is on the same response level as the stored curve. Limits for the response of the Curve Controls are defined in the UniCAP 100 Operator and Panel Software. A new calibration curve is run once a month, and/or when a new lot number of Specific IgE Conjugate is introduced.