In Vitro Diagnostics means the use of the SELEX Process or Aptamers identified through the use of the SELEX process in the assay, testing or determination outside of a living organism, of a substance in a test material.
In Vitro Diagnostics means the in-vitro testing of human Samples for the purpose of detecting, prognosing, predicting, monitoring the status of (including monitoring the effect of treatment) or screening for diseases, conditions, or infections of any kind of the human from whom the Samples were taken, but excluding the screening of blood, plasma or blood components for transfusion or for use in blood products.
In Vitro Diagnostics means the commercial use of products that detect nucleic acid sequence(s) of HCV in individual human specimens, including the use of such products for diagnosis, prognosis, monitoring or classification purposes, including without limitation use for Transplantation but specifically excluding use for Blood Screening and Plasma Fractionation (without prejudice to the provisions of the HCV Diagnostics Agreements).
Examples of In Vitro Diagnostics in a sentence
Mills, Ph.D. DirectorDivision of Radiological HealthOHT7: Office of In Vitro Diagnostics and Radiological HealthOffice of Product Evaluation and Quality Center for Devices and Radiological Health EnclosureDEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for UseForm Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020See PRA Statement below.
Any request for changes to this EUA should be submitted to the Division of Microbiology (DMD)/Office of Health Technology 7 (OHT7)-Office of In Vitro Diagnostics and Radiological Health (OIR)/Office of Product Evaluation and Quality (OPEQ)/Center for Devices and Radiological Health (CDRH) and require appropriate authorization from FDA prior to implementation.
Moreover, the ongoing work by the In Vitro Diagnostics Working Group of the Medical Device Coordination Group regarding guidance on the performance of COVID-19 tests in the context of CE-marking and common specifications under Article 9 of Regulation (EU) 2017/7465 will be taken into account.
Serious adverse events, especially unexpected biosafety concerns, should immediately be reported to the Division of Microbiology (DMD)/Office of Health Technology 7 (OHT7)-Office of In Vitro Diagnostics and Radiological Health (OIR)/Office of Product Evaluation and Quality (OPEQ)/Center for Devices and Radiological Health (CDRH) (via email: CDRH-EUAReporting@fda.hhs.gov).
Discussions on criteria and definitions will continue during summer 2021, also taking into consideration the work carried out by the In Vitro Diagnostics Working Group of the Medical Device Coordination Group9 on guidance on the performance of COVID-19 tests in the context of CE-marking and common specifications under Article 9 of Regulation (EU) 2017/746.
More Definitions of In Vitro Diagnostics
In Vitro Diagnostics means the use of the SELEX™ Process or Aptamers or PhotoAptamers identified through the use of the SELEX™ Process in the assay, testing or determination, outside of a living organism, of a substance in a test material. In Vitro Diagnostics shall include, among other things, the use of the SELEX™ Process or Aptamers or PhotoAptamers identified through the use of the SELEX™ Process in the assay, testing or determination: (a) outside of a living organism, (i) of a human substance in a test material, often to identify or follow the progression of a disease or disorder, or to select a patient for treatment; (ii) of a plant substance, animal substance or other substance in a test material, often to identify or follow the progression of a disease, process, or disorder in a human or non-human organism; and (iii) of environmental substances (as in water quality testing); and (b) of a substance on a test material such as cells (as in FACS analysis or other measurements of pathogens within biological samples).
In Vitro Diagnostics shall have the meaning provided in the [***] Agreement listed in Exhibit B, as such Agreement is in effect on the Effective Date.
In Vitro Diagnostics means the use of the SELEX Process or aptamers or photoaptamers identified through the use of the SELEX Process in the assay, testing or determination, outside of a living organism, of a substance in a test material. In Vitro Diagnostics shall include, among other things, the use of the SELEX Process or aptamers or photoaptamers identified through the use of the SELEX Process in the assay, testing or determination: (a) outside of a living organism, (i) of a human substance in a test material, often to identify or follow the progression of a disease or disorder, or to select a patient for treatment; (ii) of a plant substance, animal substance or other substance in a test material, often to identify or follow the progression of a disease, process, or disorder in a human or non-human organism; and (iii) of environmental substances (as in water quality testing); and (b) of a substance on a test material such as cells (as in FACS analysis or other measurements of pathogens within biological samples).
In Vitro Diagnostics means the use of the SELEX Process or aptamers identified through the use of the SELEX Process in the assay, testing or determination, outside of a living organism, of a substance in a test material. In Vitro Diagnostics shall include, among other things, the use of the SELEX Process or aptamers identified through the use of the SELEX Process in the assay, testing or determination: (a) outside of a living organism, (i) of a human substance in a test material, often to identify or follow the progression of a disease or disorder, or to select a patient for treatment; (ii) of a plant substance, animal substance or other substance in a test material, often to identify or follow the progression of a disease, process, or disorder in a human or non-human organism; and (iii) of environmental substances (as in water quality testing); and (b) of a substance on a test material such as cells (as in FACS analysis or other measurements of pathogens within biological samples) and (c) any other in vitro diagnostic use of the SELEX Process or aptamers identified through the use of the SELEX Process in drug development processes, including target identification, pre-clinical and clinical testing, and the following more specific examples of uses of aptamer technology: (i) to observe, through protein profiling, protein levels moving up or down in diseases or models of diseases, and to evaluate whether such proteins are sensible targets for the development of therapeutic agents; (ii) to observe coordinated expression of protein pathways in a variety of biological states in various systems; (iii) to study protein or metabolite levels during pre-clinical drug candidate evaluation in response to putative therapeutic agents during clinical trials (e.g., as markers of efficacy or response); and (iv) to study human protein or metabolite levels in response to putative therapeutic agents during clinical trials (e.g., as markers of efficacy or response). Notwithstanding the above, In Vitro Diagnostics does not include any of the above-identified activities directed at the discovery or Development of Aptamers by TAKEDA under and pursuant to the terms of this Agreement.
In Vitro Diagnostics means the use of the SELEX® Process or Aptamers or PhotoAptamers identified through the use of the SELEX® Process in the assay, testing or Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. determination, outside of a living organism, of a substance in a test material. In Vitro Diagnostics shall include, among other things, the use of the SELEX® Process or Aptamers or PhotoAptamers identified through the use of the SELEX® Process in the assay, testing or determination: (a) outside of a living organism, (i) of a human substance in a test material, often to identify or follow the progression of a disease or disorder, or to select a patient for treatment; (ii) of a plant substance, animal substance or other substance in a test material, often to identify or follow the progression of a disease, process, or disorder in a human or non-human organism; and (iii) of environmental substances (as in water quality testing); and (b) of a substance on a test material such as cells (as in FACS analysis or other measurements of pathogens within biological samples).
In Vitro Diagnostics means the use of the SELEX® Process or aptamers or photoaptamers identified through the use of the SELEX® Process in the assay, testing or determination, outside of a living organism, of a substance in a test material. In Vitro Diagnostics shall include, among other things, the use of the SELEX® Process or aptamers or photoaptamers identified through the use of the SELEX® Process in the assay, testing or determination: (a) outside of a living organism, (i) of a human substance in a test material, often to identify or follow the progression of a disease or disorder, or to select a patient for treatment; (ii) of a plant substance, animal substance or other substance in a test material, often to identify or follow the progression of a disease, process, or disorder in a human or non-human organism; and (iii) of environmental substances (as in water quality testing); and (b) of a substance on a test material such as cells (as in FACS analysis or other measurements of pathogens within biological samples). Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.
In Vitro Diagnostics means the use of the SELEX Process or Aptamers in the assay, testing or determination, outside of a living organism, of a substance in a test material. In Vitro Diagnostics shall include, among other things, the use of the SELEX Process or Aptamers in the assay, testing or determination: (a) outside of a living organism, (i) of a human substance in a test material, often to identify or follow the progression of a disease or disorder or to select a patient for treatment; (ii) of a plant substance, animal substance or other substance in a test material, often to identify or follow the progression of a disease, process or disorder in a human or non-human organism; and (iii) of environmental substances (as in water quality testing); (b) of a substance on a test material such as cells (as in FACS analysis or other measurements of pathogens within biological samples); and (c) any other in vitro diagnostic use of the SELEX Process or Aptamers in drug development processes, including target identification, pre-clinical and clinical testing, and the following more specific examples of uses of Aptamer technology: (i) to observe, through protein profiling, protein levels moving up or down in diseases or models of diseases, and to evaluate whether such proteins are sensible targets for the development of therapeutic agents; (ii) to observe coordinated expression of protein pathways in a variety of biological states in various systems; (iii) to study protein or metabolite levels during pre-clinical Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. drug candidate evaluation in response to putative therapeutic agents during clinical trials (e.g., as markers of efficacy or response); and (iv) to study human protein or metabolite levels in response to putative therapeutic agents during clinical trials (e.g., as markers of efficacy or response). Notwithstanding the above, In Vitro Diagnostics shall exclude any of the above-described uses in this Section 1.34 conducted in the Development of Anti-C5 Aptamers under this Agreement.