Product Datasheet/Brochure

Page 9 – Sang Joon Han, Access Bio, Inc.
• This product has been authorized only for the detection of proteins from
SARS- CoV-2, not for any other viruses or pathogens; and,
• This product 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-
3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
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.
V. Duration of Authorization
This EUA will be effective until the declaration that circumstances exist justifying the
authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of
COVID-19 is terminated under Section 564(b)(2) of the Act or the EUA is revoked under
Section 564(g) of the Act.
Sincerely,
RADM Denise M. Hinton
Chief Scientist
Food and Drug Administration
Enclosure