510(k) clearance
QIAstat-Dx BCID GN Plus AMR Panel
- 510(k) number
- K262168
- Applicant
- QIAGEN GmbH
- Decision date
- Sep 24, 2026
- Date received
- Jun 26, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- PEN
- Device type
- Gram-Negative Bacteria And Associated Resistance Markers
- Device class
- Class II
- Regulation
- 21 CFR 866.3365
- Advisory committee
- Microbiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Hilden, DE