QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today that it has been granted CLIA Waiver from the U.S. Food and Drug Administration (FDA), applying to its new Sofia® 2 SARS Antigen+ FIA.
BioMérieux announced on Tuesday that its BioFire SpotFire Respiratory Panel Mini has obtained CLIA wavier from the US Food and Drug Administration.
Visby Medical said that it has received 510(k) clearance and a CLIA waiver from the US Food and Drug Administration for its second-generation point-of-care sexual health test.
Chembio Diagnostics has obtained a CLIA waiver from the US Food and Drug Administration for its DPP HIV-Syphilis System, the firm announced on Friday.
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