Xpert® Xpress CoV-2 plus (XPRS-COV2-10)— 510(k) K242109

Substantially Equivalent

Cepheid®

FDA 510(k) clearance K242109 for Xpert® Xpress CoV-2 plus (XPRS-COV2-10), Substantially Equivalent on 2025-01-15. Applicant: Cepheid®.

Clearance details

Applicant: Cepheid®
Product code: Code QQX
Advisory panel: Microbiology
Date received: 2024-07-19
Decision date: 2025-01-15
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Sunnyvale, CA, US

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