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1 / 11Influenza A/B SARSCoV2 Multiplex Qualitative Rephrased detection of Influenza A/B and SARSCoV2For invited diagnostic useIVD09073025 25 test 09073050 50 test 09073100 100 test RTA.OK.688 Revision
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The evaluation of multiplex rapid refers to the assessment process for tests that can simultaneously detect multiple targets, typically used in laboratories to streamline diagnostics.
Entities such as medical device manufacturers, laboratory test developers, and other stakeholders involved in the creation and distribution of multiplex rapid tests are required to file the evaluation.
To fill out the evaluation, applicants must provide comprehensive details about the multiplex rapid test, its intended use, analytical and clinical performance data, and adhere to regulatory guidelines set forth by relevant health authorities.
The purpose of the evaluation is to ensure that the multiplex rapid tests are safe, effective, and reliable for their intended use, thereby maintaining public health standards.
Key information includes test methodology, validation studies, performance characteristics, intended uses, labeling information, and compliance with regulatory requirements.
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