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ENGLISH Organic 11dhTxB2 Test Kit (11Dehydro Thromboxane B2) For In Vitro Diagnostic Use INTENDED USE The 11dhTxB2 Test Kit is an enzyme linked immunoassay (ELISA) to determine levels of 11Dehydro
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In vitro diagnostics are medical devices or tests used to detect diseases, conditions, or infections. These tests are performed on samples such as blood, urine, or tissue in a laboratory setting.
Manufacturers, importers, and distributors of in vitro diagnostic products are required to file for regulatory approval before marketing their products.
To fill out for in vitro diagnostic, manufacturers need to provide detailed information about the product's intended use, performance data, labeling, and any potential risks or adverse effects.
The purpose of filing for in vitro diagnostic is to ensure that these medical devices are safe, effective, and accurately diagnose diseases or conditions.
Information such as the product's technical specifications, intended use, performance data, labeling, and any potential risks or adverse effects must be reported for in vitro diagnostic.
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