VITROS 350 Chemistry System - SFDA Registration ME0000004466SFDAA00001
Access comprehensive regulatory information for VITROS 350 Chemistry System in the Saudi Arabia medical device market through Pure Global AI's free database. This General IVD(Others) device is registered with Saudi Arabia SFDA under registration number ME0000004466SFDAA00001 and manufactured by Ortho Clinical Diagnostics Inc..
This page provides complete registration details including product category (Chemicals), manufacturer information, model details, and regulatory compliance data from the official Saudi Arabia SFDA medical device database. Pure Global AI offers free access to Saudi Arabia's complete medical device registry, helping global MedTech companies navigate SFDA regulations efficiently.
System used to perform clinical tests on serum urine and cerebral spinal fluid specimens.
The VITROS 250/350 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides. The slides are packaged in cartridges specific for each test type. Cartridges may contain 18, 50, or 60 slides. The analyzer uses each slide once, and after the slide is used, it is discarded. See the Instructions for Use for an explanation of each slide type and the methodologies offered. You can load up to 40 patient samples on the analyzer at a time, and continue to load trays of up to ten samples as other trays are completed. Once you have loaded cartridges, calibrated the system, and programmed the samples, the system is ready to begin processing the samples. A single test result takes approximately two to eight minutes, depending upon the type of test. The analyzer can operate 24 hours per day. If you turn on the analyzer from a cold start (when the analyzer has been off at least 15 minutes), it will be ready to begin operation in less than 20 minutes.
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