The FDA says the company's Abbott Prism HIV O Plus test can detect HIV types 1 and 2.
HIV type 2 is mostly found in West Africa, while HIV type 1 consists of various subgroups found in both the U.S. and West Africa.
The test runs on North Chicago, Ill.-based Abbott's Prism system, an automated instrument also used to test blood for hepatitis.
The new test will be used to screen for HIV in blood and organ donations.
HIV attacks the body's immune system, eventually causing AIDS. Just over 1.1 million Americans are estimated to have HIV and 232,000 do not know it, according to the Centers for Disease Control and Prevention.