FDA Advisory No. 2020-1054 || Public Health Warning Against the Purchase and Use of the Uncertified COVID-19 Test Kit “Testsealabs One Step Rapid Test- SARS-cov-2 IgG/IgM Test Cassette”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the uncertified Covid-19 test kit:

  1. “Testsealabs One Step Rapid Test- SARS-cov-2 IgG/IgM Test Cassette”

The FDA verified through post-marketing surveillance that the above mentioned medical device is not certified and/or no Special Certification has been issued as of 27 May 2020. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this uncertified medical device has not gone through the evaluation process of the FDA, the agency cannot assure its quality and safety.

Furthermore, FDA Circular No. 2020-016 entitled “Prohibition of Online Selling of FDA Certified Covid-19 Antibody Test Kits” prohibits online selling and commercial use of such products.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected].

To report any sale or distribution of unregistered/uncertified medical devices, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested

Attachment:-> FDA Advisory No.2020-1054

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