The Food and Drug Administration (FDA) informs all healthcare professionals and the general public that the advisory on Healgen® Coronavirus Ag Rapid Test Cassette (Swab) manufactured by Healgen Scientific Limited Liability Company under FDA Advisory No. 2022-0052 dated 24 January 2022 is hereby lifted pursuant to the compliance of the market authorization holder to existing and applicable laws, rules, and regulations.
The FDA issued Special Certification for the above-mentioned product with certificate number SC-2022-055 under company Newlife Pharmaceuticals Inc.
The issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to existing laws, rules and regulations.
For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected] or call (02) 8857-1900 loc. 8301.
To report any sale or distribution of uncertified COVID-19 test kits, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.
Dissemination of this advisory to all concerned is hereby requested.