K254194
- 510(k) number
- K254194
- Device name
- QIAstat-Dx BCID GPF Plus AMR Panel
- Applicant
- QIAGEN GmbH DE
- Product code
- PAM — Gram-Positive Bacteria And Their Resistance Markers
- Decision date
- 2026-08-06
- Date received
- 2025-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
510(k) Summary (official FDA PDF): K254194.pdf
Official FDA record: K254194
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.