Pre-EUA Serological Tests

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The commercial manufacturers in the list below have notified the FDA that they have validated and intend to distribute a serology test as set forth in Section IV.D of the Policy for Coronavirus Disease-2019 Tests.

If an EUA request is not submitted within a reasonable period of time (10 business days) of providing this notification, or if significant problems are identified with a test and cannot be or have not been addressed in a timely manner, FDA intends to remove the manufacturer and test from this list, would expect the manufacturer to suspend distribution of the test, and may take additional actions as appropriate. 

The commercial manufacturers in the list below provided notification to 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.

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, 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.

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