RUO definition

RUO means an Assay that is intended and labeled for “research use only”.

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RUO means Products labeled “research use only.”

RUO or “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 RUO in a sentence

• While information given by the system may be useful when used in the highly complex context with other tests which are licensed, the information provided by the system must be viewed with a certain degree of uncertainty given its RUO status.

• You acknowledge that our RUO products have not been approved, cleared, or licensed by the United States Food and Drug Administration or any other regulatory entity whether foreign or domestic for any specific intended use, whether research, commercial, diagnostic, or otherwise.

• Royalty payments will commence on sale of first product in any category (RUO, ASR, IVD) and shall be payable quarterly.

• 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.

• If Ventana or Blueprint believes such RUO Product would be detrimental to its business strategy, such considerations shall be discussed between the Parties and a good faith approach shall be mutually agreed upon by the JDC.

More Definitions of RUO

RUO means an assay intended or approved for research use only.

RUO means research use only.

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).

RUO means “research use only”, as defined in United States Code of Federal Regulations, Title 21, Paragraph 809.10(c)(2)(i).

RUO means research use only;

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.

RUO means "research use only", as defined in United States Code of Federal Regulations, Title 21, Paragraph 809.10(c)(2)(i).