The Food and Drug Administration (FDA) informs all concerned stakeholders and the general public that the following companies have failed to comply and submit documents, as required by the FDA Memorandum No. 2020-011. Thus, the Special Certification for COVID-19 Test Kits issued to the following companies are automatically revoke and cancel:
|Company’s Name||Product Name||SC Control Number||Classification|
|1||MDRX ENTERPRISE||SARS-CoV-2 ANTIBODY TEST (LATERAL FLOW METHOD)
manufactured by Guangzhou Wondfo Biotech Co., Ltd.
|2||INTELMED LABORATORIES MANUFACTURING INC||2019-nCoV ANTIBODY TEST (COLLOIDAL GOLD)
manufactured by Innovita (Tangshan) Biological Technology Co., Ltd
For more information and inquiries. Kindly contact the FDA – Center for Device Regulation, Radiation Health, and Research through e-mail address at [email protected] or call (02) 8857-1900 loc. 8301.
Dissemination of this advisory to all concerned is hereby requested.