Chembio Diagnostics Inc's (NASDAQ: CEMI) said that on December 1, it received an FDA notice for additional data related to Clinical Laboratory Improvement Amendment (CLIA) waiver submission for the DPP HIV-Syphilis test system.
Request for Additional Data Related to CLIA Waiver Submission for DPP HIV-Syphilis Test System
On December 1, 2021, we received notice from the U.S. Food and Drug Administration, or FDA, that the FDA
Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced that it has submitted a De Novo/510(k) Request to the U.S. Food and Drug
South Africa Health Products Regulatory Authority (SAHPRA) has approved Chembio Diagnostics Inc's (NASDAQ: CEMI) DPP SARS-CoV-2 Antigen test for use at the point of care.