Datametrex AI Ltd V.DM

RE:RE:FDA Approval Confirmed Here

[Jennifer2020]

No I was right the first time, is approval for emergency use.  Better DD on Yahoo Finance but responses get hidden, if people too lazy to click on replies.  Also algorithm for top response questionable imho 

https://www.fda.gov/media/137420/download

0 Christina Kang Senior Advisor Kord Partners, LLC 500 W. 190th St., Suite 200 Gardena, CA 90248 Device: U-TOP COVID-19 Detection Kit Company: SEASUN BIOMATERIALS Indication: Qualitative detection of nucleic acid from SARS-CoV-2 in oropharyngeal and nasopharyngeal swab specimens, anterior nasal and mid-turbinate nasal swabs, nasopharyngeal wash/aspirate or nasal aspirate specimens and sputum from individuals suspected of COVID-19 by their healthcare provider. Emergency use of this test is limited to authorized laboratories. Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests. Dear Ms Kang: This letter is in response to your1 request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of your product, 2 pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3). On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19. Pursuant to Section 564 of the Act, and on the basis of such determination, the Secretary of HHS then declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19 subject to the terms of any authorization issued under Section 564(a) of the Act. 3 1 For ease of reference, this letter will use the term “you” and related terms to refer to SEASUN BIOMATERIALS. 2 For ease of reference, this letter will use the term “your product” to refer to the U-TOP COVID-19 Detection Kit used for the indication identified above. 3 U.S. Department of Health and Human Services, Determination of a Public Health Emergency and Declaration Page 2 – Christina Kang, SEASUN BIOMATERIALS Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of your product, described in the Scope of Authorization of this letter (Section II), subject to the terms of this authorization.