Iowa Admin. Code r. 641-11.81
For the purpose of these rules, the following definitions shall apply:
"CLIA " means the Clinical Laboratories Improvement Act as administered by the Health Care Financing Administration.
"FDA " means the U.S. Food and Drug Administration.
"HIV" means the human immimodeficiency virus identified as the causative agent of AIDS.
"HIVhome collection kit" means a product for human immunodeficiency virus testing that provides for the specimen to be collected by an individual and then submitted to a laboratory, for determination of test results.
"HIVhome testing kit" means a product for human immunodeficiency virus testing that provides for specimen collection and determination of test results by an individual without the utilization of a laboratory.
"laboratory" means a laboratory meeting the CLIA requirements for HIV testing.
"Specimen " means a human body fluid or tissue sample.
Iowa Admin. Code r. 641-11.81