The laboratories in the list below provided notification to the FDA that they developed and validated a diagnostic SARS-CoV-2 test as set forth in Section IV.A of the Policy for Coronavirus Disease-2019 Tests. Although the FDA had previously included them on the website notification list of laboratories offering diagnostic tests under that policy, they have now been removed from that notification list and placed on the list below. As noted in the guidance, among other things, if significant problems are identified with such a test that cannot be or have not been addressed in a timely manner, the FDA intends to remove the laboratory from the notification list. The FDA has determined that there are significant problems with the tests being offered by the laboratories listed below that cannot be or have not been addressed in a timely manner. As such, these laboratories have now been removed from the notification list and placed on the removal list below. Laboratories may also voluntarily withdraw their test notification and/or their EUA, and such tests are noted with an asterisk.

The FDA expects that laboratories on this list will not offer or use their diagnostic SARS-CoV-2 laboratory developed test that was previously on the notification list. Other tests that are EUA authorized may be available for use by these laboratories, in accordance with those EUAs.

The commercial manufacturers in the list below provided notification to the FDA that they validated and intended to distribute a diagnostic test as set forth in Section IV.C of the Policy for Coronavirus Disease-2019 Tests. The FDA had previously included them on the website notification list of commercial manufacturers distributing diagnostic test kits under that policy, but they have now been removed from that notification list and placed on the list below. As noted in the guidance, if an EUA request is not submitted by a commercial manufacturer of a diagnostic test within a reasonable period of time, or if significant problems are identified with such a test that cannot be or have not been addressed in a timely manner, the FDA intends to remove the manufacturer and test from the notification list. Commercial manufacturers may also voluntarily withdraw their test notification, and such tests are noted with an asterisk.

The FDA expects that the tests on this list will not be distributed unless and until an EUA is issued for the test, and the FDA may take additional actions as appropriate.

The commercial manufacturers in the list below provided notification to the FDA that they validated and intended to distribute a serology test as set forth in Section IV.D of the Policy for Coronavirus Disease-2019 Tests. The FDA had previously included them on the website notification list of commercial manufacturers distributing serology test kits under that policy, but they have now been removed from that notification list and placed on the list below. As noted in the guidance, if an EUA request is not submitted by a commercial manufacturer of a serology test within a reasonable period of time, or if significant problems are identified with such a test that cannot be or have not been addressed in a timely manner, the FDA intends to remove the manufacturer and test from the notification list. Commercial manufacturers may also voluntarily withdraw their test notification, and such tests are noted with an asterisk.

The FDA expects that the tests on this list will not be distributed unless and until an EUA is issued for the test, and the FDA may take additional actions as appropriate.

Recommendations for clinical laboratories and health care providers regarding these tests may be found in the FDA's June 19, 2020, Letter to Clinical Laboratory Staff and Health Care Providers.