Cepheid - FDA 510(k) Cleared Devices

Cepheid, is a molecular diagnostics company based in Sunnyvale, US. The company enables access to molecular diagnostic testing globally through its Xpert platform and related solutions.

Cepheid has received 57 FDA 510(k) clearances from 60 total submissions since its first clearance in 2006. The company specializes in Microbiology devices, which represent 93% of its regulatory submissions. Its latest FDA 510(k) clearance in 2026 demonstrates continued active development and market presence.

Recent cleared devices span respiratory diagnostics, infectious disease detection, antimicrobial resistance identification, and hematology testing. The Xpert product line includes assays for COVID-19, influenza, RSV, gastrointestinal pathogens, bloodstream infections, and emerging infectious diseases. The company also offers diagnostic instruments and software platforms designed for point-of-care and laboratory settings.

Explore Cepheid's complete FDA 510(k) clearance history, including specific device names, product codes, and clearance dates in the database.

510(k) submissions have been managed by Cepheid® as regulatory consultant.