AMDI Fast PCR System Gains FDA Clearance and CLIA Waiver for 10‑Minute Respiratory Test
Aiying Sun, EVP, Quality, Regulatory and Clinical Affairs at AMDI. “Pursuing the FDA’s dual 510(k) clearance and CLIA waiver pathway was a deliberate strategy to bring this innovation to market with the validation needed for clinical use in the urgent care setting
June 16, 2026