A product becomes an IVD when it is intended to be used for the examination of human specimens, including blood, urine, and tissue, in order to provide information for diagnostic, monitoring or compatibility purposes. IVD products can include reagents, instruments, and systems used to perform tests on samples for the detection, quantification, or measurement of specific analytes or biomarkers. The classification of a product as an IVD depends on its intended use and its compliance with applicable regulatory requirements.
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