FDA warns use of uncertified Covid-19 test kits for self-administration

Published January 27, 2021, 11:29 AM

by Jane Kingsu-Cheng

Under the Food and Drug Administration Advisory number 2021-0104, FDA issued a memo last January 21 that there is no FDA certified Covid-19 test kits for self administration.

photo from freepik.com

The memo reminds “all healthcare professionals and the general public are advised not to purchase and use these in-vitro devices. All concerned establishments are warned not to distribute, advertise, or sell the said Uncertified medical device until FDA Special Certification is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.”

The Bureau of Customs is also reminded to restrain the entry of this uncertified product.

 
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