Ted posted this on the other board, which I believ
Post# of 22453
Quote:Note, there are two response time frames specified. You should take immediate action to address the violations relating to your firm’s sale or distribution of the SARS-CoV-2 Antigen Rapid Qualitative Test. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and/or effective for a COVID-19-related use for which they have not been approved, cleared, or authorized by FDA and that you do not make claims that adulterate or misbrand the products in violation of the Act.