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Allergen ImmunoCAP™ is the solid phase component of the Pharmacia & Upjohn in vitro immunodiagnostic systems which measure specific IgE to the respective allergen bound to the ImmunoCAP™. Allergen ImmunoCAP™ are intended to be used with Pharmacia CAP System™ RAST FEIA and UniCAPTM Specific IgE in vitro diagnostic assays. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjynction with other findings, and is to be used in clinical laboratories, as well as, physician office laboratories.

The Allergen ImmunoCAP™ consists of a cellulose sponge matrix to which allergenic components are covalently coupled. The matrix is encased in a small round plastic capsule. This capsule is at tha same time a holder of the matrix for convenient automation and a reaction chamber. The sponge matrix is manufactured from activated cellulose derivative to which allergen extract solution is added under defined optimized conditions for the allergen coupling. This solid phase is an excellent carrier of allergens and provides favorable reaction conditions. The Allergen ImmunoCAP™ m4 contains allergens from the mold Mucor racemosus, Allergen ImmunoCAP™ m8 from Helminthosporium halodes (both spores and mycelium). Identical sources and extracts are used for both the predicate device Phadebas RAST Paper Disc and ImmunoCAP™ The Allergen ImmunoCAP™ k70 contains allergens extracted from the Green Coffee Bean. Identical source and extract is also used for both the predicate device Phadebas RAST Paper Disc and ImmunoCAP™

UniCAP Phadiatop Assay is an in vitro qualitative assay for the differential determination of IgE antibodies specific to inhalant allergens in human serum and plasma. UniCAP Phadiatop 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.

UniCAP is a fully integrated and automated system for the determination of total and specific IgE in human serum or plasma. The UniCAP system includes the UniCAP 100 instrument with software for immunodiagnostic testing; UniCAP RM External Software; UniCAP reagents, in this submission reagents for the differential determination of IgE antibodies specific to inhalant allergens.

UniCAP Specific IgE Assay is an in vitro semi-quantitative assay for the 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. Information Specific to Latex k82 Allergen UniCAP Specific IgE Assay, Latex k82 test result may be used as an aid in the clinical diagnosis of patients with suspected latex allergy.

The allergen of interest, in this case Latex, covalently coupled to ImmunoCAP, reacts with the specific IgE in the patient serum specimen. After washing away non-specific IgE, enzyme labelled antibodies against IgE are added to form a complex. After incubation, unbound enzyme-anti-IgE is washed away and the bound complex is then incubated with a developing agent. After stopping the reaction, the fluorescence of the eluate is measured. The higher the response value, the greater the quantity of specific IgE present in the specimen. To evaluate the test results, the response for the patient sample is compared directly to the response for the calibrators. UniCAP 100 instrument with built in software processes all steps of the assay and prints results automatically after the assay is completed.

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

UniCAP Total IgE Flurorimmunoassay is an in vitro assay for the quantitative measurement of circulating total IgE in human serum or plasma. UniCAP Total 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 clinical findings, and is to be used in clinical laboratories, as well as, physician office laboratories. Pharmacia Total IgE Control LMH is intended for laboratory use in monitoring the performance of total IgE measurements as determined by Phadebas IgE PRIST /Phadezym IgE PRIST, Pharmacia IgE RIA, Pharmacia IgE RIACT, Pharmacia CAP System IgE RIA/FEIA and UniCAP Total IgE.

UniCAP is a fully integrated and automated system for the determination of total IgE in human blood serum or plasma. The UniCAP system includes the UniCAP 100 instrument with software for immunodiagnostic testing; UniCAP RM External Software; UniCAP reagents, in this submission reagents for the measurement of total IgE, and Pharmacia Total IgE Control LMH. 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 Total IgE Conjugate or Anti- IgE ImmunoCAP is introduced.

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.