On its weekly call, the agency also stressed the importance of reporting test results, including those from home-based tests, to public health authorities.
According to some analysts, the selloff in IVD company shares may be an overreaction, and SARS-CoV-2-related testing will be needed for some time in the future.
Following FDA's revocation of the firm's antibody-based test for the coronavirus in June, Chembio is seeking new EUAs for an antibody and antigen test for SARS-CoV-2.
The firm submitted a new Emergency Use Authorization application to the FDA for a serology IgM/IgG test for SARS-CoV-2 after the agency revoked an earlier EUA for a similar test.