510(k) K233100 · QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
QIAstat-Dx® Respiratory Panel Plus
| Applicant | QIAGEN GmbH, Hilden, DE |
| Decision | Substantially Equivalent, May 10, 2024 |
| Received | Sep 26, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233100
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2025 | Qiagen Sciences LLC Brand Name: QIAstat-Dx
Product Name: QIAstat-Dx Respiratory Panel Plus
Reference Number (REF): 691224
Software Version: n/a
Component: n/a Open, Classified |
QOF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.