Human In Vitro Diagnostics definition

Human In Vitro Diagnostics. (“HIVD”) shall mean the field of use comprising the in vitro measurement, observation or determination of one or more protein or nucleic acid targets in a sample obtained from a human being for medical management of that human being or for blood banking, bone marrow banking or similar banking of human tissues for human medical management, and pre-clinical uses and clinical trials for the foregoing uses, even if kits for such purposes are labeled “Research Use Only” or “Investigational Use Only.” HIVD does not include research and development for any purpose other than as set forth in Section 2.1(c), and specifically excludes human identity testing or parentage testing, forensics, agricultural testing, food testing, quality control and assurance, detection of nucleic acid sequences in persons or in living cells, in vitro fertilization and diagnoses therefor, tests on materials obtained from animals other than humans, tests on plants, or any other testing not specifically included in the previous paragraph.
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Human In Vitro Diagnostics means the in vitro measurement, observation or determination of attributes, characteristics, diseases, traits or other conditions of a human being for the medical management of that human being.
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Human In Vitro Diagnostics. ("HIVD") shall mean the field of use comprising the in vitro measurement, observation or determination of one or more nucleic acids in a sample obtained from a human being for medical management of that human being or for blood banking, bone marrow banking or similar banking of human tissues for human medical management, and pre-clinical uses and clinical trials for the foregoing uses, even if kits for such purposes are labeled "Research Use Only" or "Investigational Use Only." HIVD does not include research and development for any purpose, other than as set forth in 2.1(c), human identity testing or parentage testing, forensics, agricultural testing, food testing, quality control and assurance, detection of nucleic acid sequences in persons or in living cells, in vitro fertilization and diagnoses therefor, tests on materials obtained from animals other than humans, tests on plants, or any other testing not specifically included in the previous paragraph.
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Examples of Human In Vitro Diagnostics in a sentence

  • For Product Purchased for Use in Human In Vitro Diagnostics or Pharmaceutical Therapeutics Research and Development The first $[*********] of Net Sales: the greater of: [***]% of Net Sales of Tests, or $[****] per Test.

  • GPRO shall include on and with each HPV TMA Test Kit a statement to the effect that the product is sold and intended for use only in Human In Vitro Diagnostics and that all other implied licenses are expressly disclaimed.

  • The business of Celera Genomics will include the field of Human In Vitro Diagnostics (the HIVD Field).

  • United States Bureau of Reclamation, 426 F.3d 1082, 1090-95 (9th Cir.2005).

  • Table 9-3 shows maximum permitted criteria of ammonia- nitrogen for protection of freshwater aquatic life.Different types of wastewater are discharged from the LNG Plant site.

  • Unless and until ABI reasonably instructs differently, the Notice shall be: Purchase of this instrument, Serial No. ____________, conveys a limited non-transferable immunity from suit for the purchaser’s own internal research and development and for use in applied fields other than Human In Vitro Diagnostics under one or more of U.S. Patents Nos.

Related to Human In Vitro Diagnostics

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • Animal means any nonhuman animate being endowed with the power of voluntary action.

  • Radiopharmaceutical means any drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any non-radioactive reagent kit or radionuclide generator that is intended to be used in the preparation of any such substance, but does not include drugs such as carbon-containing compounds or potassium-containing salts that include trace quantities of naturally occurring radionuclides. The term also includes any biological product that is labeled with a radionuclide or intended solely to be labeled with a radionuclide.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Biological agent shall mean any pathogenic (disease producing) micro-organism(s) and/or biologically produced toxin(s) (including genetically modified organisms and chemically synthesized toxins) which cause illness and/or death in humans, animals or plants.

  • Licensed health care practitioner means a physician, as defined in Section 1861(r)(1) of the Social Security Act, a registered professional nurse, licensed social worker or other individual who meets requirements prescribed by the Secretary of the Treasury.