K230440

Substantially Equivalent

Xpert® Xpress CoV-2 plus

Applicant: Cepheid®
Product code: QQX
Advisory panel: Microbiology
Date received: 2023-02-21
Decision date: 2023-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.