K250080
- 510(k) number
- K250080
- Device name
- QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini
- Applicant
- QIAGEN GmbH DE
- Product code
- QOF — Multi-Target Respiratory Specimen Nucleic Acid Test
- Decision date
- 2025-08-27
- Date received
- 2025-01-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
510(k) Summary (official FDA PDF): K250080.pdf
Official FDA record: K250080
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.