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.

  • 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.

  • 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).

  • Unless and until ABI reasonably instructs differently, the Notice shall be: This Dyad Disciple, Serial No. , in combination with its immediately attached Bio-Rad sample block module(s) and a personal computer loaded with Disciple Desktop software, constitutes a thermal cycler whose purchase 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

  • in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

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

  • Drug therapy management means the review of a drug therapy regimen of a patient by one or more pharmacists for the purpose of evaluating and rendering advice to one or more practitioners regarding adjustment of the regimen.

  • Biological safety cabinet means a containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49.

  • 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;

  • Therapeutic school means a residential group living facility:

  • Diagnostic mammography means a method of screening that

  • Cosmetology means any one and/or combination of practices generally and usually performed by and known as the occupation of beauty culturalist, cosmeticians, cosmetologists or hairdressers or any person holding him or herself out as practicing cosmetology in or upon a place or premises. Cosmetology shall include, but otherwise not be limited to, the following: embellishing, arranging, dressing, curling, waving, cleansing, beautifying, cutting, singeing, bleaching, coloring, or similar work upon the hair of any person by any means and with hands or mechanical or electrical apparatuses, devices or appliances or by use of cosmetic preparations, antiseptics, tonics, lotions, creams or otherwise, massaging, cleansing, stimulating, manipulating, exercising, beautifying or similar work, the scalp, face, neck, arms, hands, bust or upper part of the body, or manicuring, pedicuring or sculpting the nails of any person.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • Licensed health care professional means a person who possesses a professional medical license that is valid in Oregon. Examples include, but are not limited to, a registered nurse (RN), nurse practitioner (NP), licensed practical nurse (LPN), medical doctor (MD), osteopathic physician (DO), respiratory therapist (RT), physical therapist (PT), physician assistant (PA), or occupational therapist (OT).

  • 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.

  • Medical management technique means a practice which is used to control the cost or utilization of health care services or prescription drug use. The term includes, without limitation, the use of step therapy, prior authorization or categorizing drugs and devices based on cost, type or method of administration.

  • Marijuana products means concentrated marijuana products and marijuana products that are comprised of marijuana and other ingredients and are intended for use or consumption, such as, but not limited to, edible products, ointments, and tinctures.

  • 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.

  • Medical cannabis means the same as that term is defined in Section 26-61a-102.

  • Diagnostic x-ray system means an x-ray system designed for irradiation of any part of the human or animal body for the purpose of diagnosis or visualization.

  • Marijuana-infused products means products that contain marijuana or marijuana extracts and are intended for human use. The term "marijuana-infused products" does not include useable marijuana.

  • Occupational therapy means services provided by a qualified occupational therapist, and includes:

  • Licensed assistant behavior analyst means a person who holds current certification or meets the standards to be certified as a board certified Assistant Behavior Analyst issued by the Behavior Analyst Certification Board, Inc., or any successor in interest to that organization, who is licensed as an Assistant Behavior Analyst by the Board of Psychological Examiners and who provides Behavioral Therapy under the supervision of a Licensed Behavior Analyst or psychologist.

  • Bioassay means the determination of kinds, quantities or concentrations and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these rules, “radiobioassay” is an equivalent term.