Diagnostic Use definition

Diagnostic Use means the use of Biologicals, Non-MAP Collaboration Target(s), MAP Collaboration Targets, Discovery Target(s), Collaboration Compound(s) and/or Product(s) (i) for any and all uses in the diagnosis and/or ongoing evaluation of a disease or medical condition in humans or animals, where (ii) MERCK, in its reasonable judgment, determines that the Product for such use described in (i) above is useful in the regulatory approval, marketing and/or sale of a Product for Therapeutic Use.
Diagnostic Use means use solely for diagnosis, prediction, detection or imaging of any disease, disorder, state, or condition where: the Product (i) is packaged, labeled and sold solely for diagnosis, prediction, detection or imaging of any disease, disorder, state or condition and (ii) does not on its own or in combination with another product(s) rely on the pharmacodynamic effect of a Non-peptide GnRH Antagonist for its use or application.
Diagnostic Use as the context requires, shall mean the use of Royalty Product(s) for measurement, observation or determination of attributes, characteristics, disease, traits or other conditions of human beings or animals in vitro for diagnostic purposes as part of an FDA-approved assay (or an equivalent approval from foreign regulatory agencies) or a Research Use Only (RUO) assay as regulated under Clinical Laboratory Improvement Amendments (CLIA) or a RUO assay subject to similar government approval or supervision in a non-US country).

Examples of Diagnostic Use in a sentence

  • Evaluation of 2 Real-Time PCR Assays for In Vitro Diagnostic Use in the Rapid and Multiplex Detection of EGFR Gene Mutations in NSCLC.

  • In consideration for the non-exclusive license described in Section 2.1 Licensee shall pay to Licensor a non-refundable, non-creditable fee in the amount of US Dollars […***…] (the “Companion Diagnostic Use Option Fee”).

  • The analysis should be performed by trained laboratory professionals.For In Vitro Diagnostic Use.

  • If Regulus enters into such a license or agreement under which Regulus may owe a payment to a Licensor for such Diagnostic Use after the Effective Date, AstraZeneca shall only be liable to pay any contribution to such payments that Regulus may be obliged make to Licensor if such agreements was entered into with AstraZeneca’s consent.

  • Do not freeze.Warnings and PrecautionsFor in vitro Diagnostic Use.


More Definitions of Diagnostic Use

Diagnostic Use any and all uses of the Licensed Materials, by the Licensee for the development or implementation of assays intended for diagnostics use, including but not limited to: (i) Development of platforms or assays intended for diagnostic use; and (ii) Validation or verification of platforms or assays intended for diagnostic use; and (iii) Development of reagents intended for diagnostic use;
Diagnostic Use any and all uses of the Licensed 「診断利⽤」ライセンシーによる、診断⽤途を意図し Materials, by the Licensee for the development or たアッセイの開発または実施のためのライセンス対象 implementation of assays intended for diagnostics 物の⼀切の利⽤。ただし、(i) 診断⽤途を意図したプ use, including but not limited to: (i) Development of ラットフォームまたはアッセイの開発、(ii) 診断⽤途 platforms or assays intended for diagnostic use; and を意図したプラットフォームまたはアッセイの妥当性
Diagnostic Use means the use of a product for diagnosis, staging or monitoring of indications or medical conditions.
Diagnostic Use as the context requires, shall mean the use of Royalty Product(s) for […***…] as part of an FDA-approved assay (or an equivalent approval from foreign regulatory agencies) or a Research Use Only (RUO) assay as regulated under Clinical Laboratory Improvement Amendments (CLIA) or a RUO assay subject to similar government approval or supervision in a non-US country).
Diagnostic Use means the diagnostic use of microarrays as a component of a Diagnostic Product for the measurement, observation or determination of attributes, characteristics, diseases, traits or other conditions of a human being or human pathogen for the medical management of a human or where the results of such use are communicated directly or indirectly to a patient or a medical professional providing care to a patient for the purpose of treating such patient but excluding any use for which an Array is utilized (i) at the point of care for the patient or in a physician’s office (if such physician’s office would not constitute a Customer hereunder); or (ii) by a consumer who purchased such microarray via retail or another direct-to-consumer sales channel).
Diagnostic Use means use in a clinical diagnostic setting where data from an individual sample is given to such individual or the individual’s care giver for the diagnosis or treatment of a medical condition of an individual. For clarity and without limiting the foregoing, use for any of the following purposes constitutes a Diagnostic Use: (i) use in clinical trials (with the exception of clinical research performed in the development of diagnostic products); (ii) determining predisposition to a medical condition; (iii) screening (e.g., a pre-natal test for a medical condition of an individual); (iv) diagnosis (e.g., where a patient has presented with symptoms); (v) prognosis; (vi) therapy selection (e.g., to determine appropriate and safe levels of a prescribed therapeutic); or (vii) monitoring (e.g., to measure the efficacy of a therapeutic). Notwithstanding the foregoing, “Diagnostic Use” includes any use requiring clearance, approval, or registration with the FDA or any similar regulatory body including any EU Notified Body.
Diagnostic Use means use in a clinical setting where data from an individual human sample is given to such individual or the individual’s care giver for the purposes of screening, determining predisposition, diagnosis, classification, determining prognosis, determining drug efficacy or safety, monitoring therapy, or any other use requiring clearance, approval, or registration with the FDA or any similar regulatory body including any EU Notified Body.