Fluoroscopic imaging assembly means a subsystem in which X-ray photons produce a visual image. It includes the image receptor(s) such as the image intensifier and spot-film device, electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.
Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.
Cannabinoid edible means food or potable liquid into which a cannabinoid concentrate, cannabinoid extract or dried marijuana leaves or flowers have been incorporated.
COVID-19 symptoms means fever of 100.4 degrees Fahrenheit or higher, chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea, unless a licensed health care professional determines the person’s symptoms were caused by a known condition other than COVID-19.
Animal means any nonhuman animate being endowed with the power of voluntary action.
Opioid means a drug that produces an agonist effect on opioid receptors and is indicated or used for the treatment of pain.
Corrosion inhibitor means a substance capable of reducing the corrosivity of water toward metal plumbing materials, especially lead and copper, by forming a protective film on the interior surface of those materials.
Precursor means any chemical reactant which takes part at any stage in the production by whatever method of a toxic chemical. This includes any key component of a binary or multicomponent chemical system.
Infection means the entry and development or multiplication of an infectious agent in the body of humans and animals that may constitute a public health risk;
Disease means an alteration in the state of the body or of some of its organs, interrupting or disturbing the performance of the functions, and causing or threatening pain and weakness or physical or mental disorder and certified by a Medical Practitioner.
Opioid antidote means any drug, regardless of dosage amount or method of administration, which has been approved by the United States Food and Drug Administration (FDA) for the treatment of an opioid overdose. “Opioid antidote” includes, but is not limited to, naloxone hydrochloride, in any dosage amount, which is administered through nasal spray or any other FDA-approved means or methods.
Prosthesis means an artificial substitute for a missing body part.
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.
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.
Biomarker means a parameter or characteristic in a patient or Patient Sample, the measurement of which is useful (a) for purposes of selecting appropriate therapies or patient populations or monitoring disease susceptibility, severity or state, or monitoring therapies for such patient and/or (b) for predicting the outcome of a particular treatment of such patient.
Wild animal means any mammal, bird, fish, or other creature of a wild nature endowed with sensation and the power of voluntary motion.
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.
HIV means human immunodeficiency virus.
Embryo/fetus means the developing human organism from conception until the time of birth.
Radionuclide means a radioactive element or a radioactive isotope.
Vaccine means a specially prepared antigen which, upon administration to a person, will result in immunity and, specifically for the purposes of this rule, shall mean influenza and pneumococcal vaccines.
Opioid antagonist means a drug that binds to opioid
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.
Fluoroscopy means a technique for generating x-ray images and presenting them simultaneously and continuously as visible images. This term has the same meaning as the term "radioscopy" in the standards of the International Electrotechnical Commission.
Antipsychotic medications means that class of drugs
Diagnostic mammography means a method of screening that