Iowa Administrative Code
Agency 641 - Public Health Department
Chapter 11 - Human Immunodeficiency Virus (HIV) Infection and Acquired Immune Deficiency Syndrome (AIDS)
Rule 641-11.81 - Definitions

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.