Clearance Summary
QIAstat-Dx BCID GPF Plus AMR Panel received FDA 510(k) clearance under submission number K254194, sponsored by QIAGEN GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2026-08-06.
- Submission: K254194
- Applicant / Sponsor: QIAGEN GmbH
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3365
- Decision date: 2026-08-06
Classification & Regulation
This clearance is catalogued under FDA product code PAM and 21 CFR 866.3365, within the Microbiology review panel as a Class II device.