IUO assay definition
IUO assay means an Assay (which may be based on a Background Assay) that is developed by Illumina or its Affiliates pursuant to this Agreement for investigational use only with the Partner Product.
IUO assay means an assay for investigational use only that meets certain clinical and manufacturing standards and which is used in Clinical Trials to gather data for submission as required by the FDA to obtain regulatory approval as an IVD. “IVD” means an IUO assay that has obtained regulatory approval by the FDA for marketing thereof and which is classified as a Class III device.
Examples of IUO assay in a sentence
In relation to the development of the IUO assay and the IVD kit, subject to and without limiting the terms and conditions of the MCA, SYROS shall be responsible for the following: • SYROS shall be solely responsible for the clinical testing for tamibarotene (formerly SY-1425) using the clinical trial assay.