The cleared assays included point-of-care and home tests for infectious and chronic diseases and drugs of abuse.
NEW YORK – Lex Diagnostics said on Monday that it has obtained 510 (k) clearance and CLIA waiver from the US Food and Drug Administration for its Velo point-of-care molecular diagnostic system and an ...
The system is intended for use in urgent care clinics, primary care settings, physician office laboratories, and pharmacies.
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