KarmaCare™ COVID-19 MDX RT-PCR Test Disclaimer
Disclaimer: Conditions Related to Advertising and Promotion
A. All descriptive printed matter, including advertising and promotional materials, relating to the use of your product shall be consistent with the authorized labeling, as well as the terms set forth in this EUA and the applicable requirements set forth in the Act and FDA regulations.
B. No descriptive printed matter, including advertising or promotional materials, relating to the use of your product, may represent or suggest that this test is safe or effective for the detection of SARS-CoV-2.
C. All descriptive printed matter, including advertising and promotional materials, relating to the use of your product, shall clearly and conspicuously state that:
- This test has not been FDA cleared or approved.
- This test has been authorized by FDA under an EUA for use by authorized laboratories.
- This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
D. The emergency use of your product as described in this letter of authorization must comply with the conditions and all other terms of this authorization.