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 use of products that detect nucleic acid sequence(s) of HCV and/or HIV in individual human specimens, including the use of such products for diagnosis, prognosis, monitoring or classification purposes, but specifically excluding use for Transplantation Screening, Blood Screening, and Plasma Fractionation Screening.
Examples of In Vitro Diagnostics in a sentence
In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2.
Gansel | bioMérieuxAnalyzing microbiology In Vitro Diagnostics data using the OMOP CDM and SNOMED CT encodingM.
For example, the World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) are Official Observer to the MDSAP Regulatory Authority Council (RAC) and Subject Matter Expert (SME) Work Group.
If you are seeking another waiver type (e.g., Planned Emergency Research, Waiver of Parental Permission to Protect Child Participants, Enforcement Discretion for In Vitro Diagnostics, etc.
The WHO Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD) oversees the process.
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 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 quantitative or qualitative analysis of samples of human origin intended to assist clinicians in the identification, diagnosis, monitoring or treatment of disease in humans.
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 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 [***] other [***], the [***] of the [***] or Aptamers or[***] through the [***] of the [***] in the [***] or [***]: (a) [***] of a [***], (i) of a [***] in a [***], often to [***] or [***] of a [***], or to [***] for [***](ii) of a [***] or other [***] in a [***], often to [***]or [***] the [***] of a [***], or [***] in a [***] or [***]and (iii) of [***] (as in [***]; (b) of a [***] on a [***] such as [***] (as in [***] or other [***] of [***] within [***]; and (c) any [***] in vitro diagnostic [***] of the [***] or Aptamers or [***] through the [***] of the [***] in