Research Use Only definition

Research Use Only or “RUO” means an (i) in vitro diagnostic product that is in the laboratory research phase of development and is being shipped or delivered for an investigation that is not subject to 21 C.F.R. Part 812 (such a product is not represented as an effective in vitro diagnostic product or intended for clinical diagnostic use) or (ii) certain products, such as instruments, systems, and reagents that are labeled for research use only and intended for use in the conduct of non-clinical laboratory research with goals other than development of a commercial in vitro diagnostic product, i.e., these products are used to carry out research and they are not themselves the object of the research (these include products intended for use in discovering and developing medical knowledge related to human disease and conditions; for example, instruments and reagents intended for use in research attempting to isolate a gene linked with a particular disease may be labeled for research use only when such instruments and reagents are not intended to produce results for clinical use).

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Research Use Only means research that is not-for-profit, internal research, or research for evaluation purposes. The Research Use Only specifically excludes using the Product by the Licensee in any activity for consideration.

Research Use Only means an IVD for research use only that meets certain manufacturing standards and which is intended to be used in non-clinical studies, including to gather data for submission as required by the FDA or another Regulatory Authority in support of an IUO or an Approved IVD.

Examples of Research Use Only in a sentence

The Software is labeled with a For Research Use Only or similar labeling statement and the performance characteristics of the Software have not been established and the Software is not for use in diagnostic procedures.
The Product is labeled with a For Research Use Only or similar labeling statement and is not for use in diagnostic procedures.
In addition, each Party may Commercialize directly or through a distributor any primers or probes outside the Alliance Field, provided that such primers or probes (i) are prominently labeled “For Research Use Only.
Email: ▇▇▇▇▇▇▇@▇▇▇▇▇▇▇▇▇.▇▇▇ Web: ▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇▇.▇▇▇ For Research Use Only.
Customer acknowledges that CyTOF and its Associated Fluidigm Products are sold: For Research Use Only.
The Subject Service is labeled with a For Research Use Only or similar labeling statement and the performance characteristics of the Subject Service have not been established and the Subject Service is not for use in diagnostic procedures.
Unless otherwise labeled, all other goods are intended to be made commercially available “For Research Use Only.
The Subject Service is labeled with a For Research Use Only or similar labeling statement and the performance characteristics of the Subject Service have not been established and the Subject Service is not intended for use in diagnostic procedures.
Title: Interim Director Title: VP, IP and Legal Affairs Date: February 22, 2007 Date: 2/28/2007 Fields of Use: Human clinical diagnostics field, including Research Use Only (RUO), Investigational Use Only, (IUO), Analyte Specific Reagents (ASR), and In Vitro Diagnostic (IVD) fields of use for anticoagulant dosing.
In the event that any Intermediate or Raw Material is accompanied by a label or statement stating that such Intermediate or Raw Material is “For Research Use Only.

More Definitions of Research Use Only

Research Use Only means research that is not-for profit, internal research, or research that is for the purposes of evaluating use of the Licensed Products for commercial purposes.

Research Use Only means a use solely related to research purposes excluding diagnostic use.

Research Use Only or “RUO” as applied to Products or Instrument Systems, means that such Products or Instrument Systems are suitable for use without a Regulatory Approval by an end-user solely for the limited purpose of the end user’s internal research. An ASR-designated reagent shall not be considered a RUO reagent.

Research Use Only or “RUO” has the meaning ascribed to the term “research use only” as defined in 21 C.F.R. § 809.10(c)(2)(i) and used by the FDA in its applicable regulations and guidance as of the time of any reference thereto.

Research Use Only means only for research and development applications within the life sciences field (including without limitation, drug discovery, drug development, medical research, fermentation research and agricultural research), but expressly excluding any research where the results of any test or assay are used for Patient Management.