The test kit has not been FDA cleared or approved, however, distribution and use of the test kits follow the U.S. Food and Drug Administration (FDA) February 4, 2020, issuance of an Emergency Use Authorization (EUA). The tests are being shipped through the International Reagent Resource (IRR), a CDC-established mechanism that distributes laboratory reagents domestically and globally.

Initially, about 200 test kits will be distributed to U.S. domestic laboratories and a similar amount will be distributed to select international laboratories. Each test kit can test approximately 700 to 800 patient specimens. Additional test kits will be produced and made available for ordering in the future from the IRR. At this time, each laboratory that places an order will receive one 2019-nCoV test kit.

The IRR is accepting orders for 2019-nCoV tests from qualified laboratories. This includes 115 qualified U.S. laboratories, such as state and local public health laboratories and Department of Defense (DoD) laboratories, as well as 191 qualified international laboratories, such as the World Health Organization (WHO) Global Influenza Surveillance Response System (GISRS) laboratories.

This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of 2019-nCoV under Section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.