Reagents and materials provided {Ans: A list of the collection devices, controls, reagents, and other supplies included in the test kit. describes each component in detail, including the number of tests in the kit and the types and amounts of reagents and supplies.}Quality Control (QC) {Ans: The application of methods to ensure that test results are reliable and valid and that errors are detected and eliminated}CLIA {Ans: Clinical Laboratory Improvement Amendment 1988. which established standard for improving the quality of Laboratory Testing in the United States. Consists of federal regulations governing or facilities that perform laboratory tests for health assessment or for the diagnosis, prevention, or treatment of disease.}Reagent {Ans: A substance that produces a reaction with a patient specimen that allows detection or measurement of the substance by the test system}non waived test {Ans: A complex Laboratory test that does not meet the CLIA criteria for waiver and is subject to the CLIA regulations}Waived tests {Ans: a Laboratory test that meets the CLIA criteria for being a simple procedure that is easy to perform and has a low risk of erroneous test results. waived tests include tests that have been FDA-approved for use