FDA May Be Considering More Restrictive Approach with Research Use Only Assays Research use only (RUO) products are ubiquitous in the life science industry. They are widely sold, prominently displayed ...
Last spring, we wrote about a warning letter the United States Food & Drug Administration (“FDA” or the “Agency”) issued to Agena Bioscience Inc. (the “Agena Warning Letter”)[1] for allegedly ...
QIAGEN N.V. QGEN recently announced the launch of its QuantiFERON SARS-CoV-2 Research Use Only (“RUO”) solution to gain better insights into the COVID-19 infection. Notably, the RUO solution detects T ...
The FDA actively regulates medical devices intended for diagnostic use. Diagnostic kits intended for diagnostic use face the full panoply of FDA regulation. In sharp contrast, research use only (RUO) ...
In vitro diagnostics, or IVDs, have a somewhat unique position among the gamut of products that the Food and Drug Administration (FDA) oversees and regulates on behalf of the U.S. public. IVDs are ...
CORALVILLE, Iowa--(BUSINESS WIRE)--FBB Biomed today announced it has signed a Master Services Agreement with Verici Dx plc (AIM: VRCI.L), for Laboratory Services for Research-Use-Only (RUO) (FDA ...
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