On May 6, 2020, PharmaCyte Biotech announced it had received Medical Devices Establishment Registration with the FDAﾒs Center for Devices and Radiological Health (CDRH). The CDRH requires this registration for companies that plan to import medical devices from overseas suppliers. The company also established itself as the sole U.S. agent for Hai Kang Life Corp. for the importation of SARS-CoV-2 in vitro diagnostic test kits. The company plans to market its PCR-based diagnostic tests kits to Clinical Laboratory Improvement Amendments certified labs throughout the U.S.