QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini (K250080)
Description
QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini by QIAGEN GmbH, an FDA 510(k) cleared microbiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250080
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini (K250080) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242353 | QIAstat-Dx Respiratory Panel Mini | QIAGEN GmbH | 2024 |
| K233100 | QIAstat-Dx® Respiratory Panel Plus | QIAGEN GmbH | 2024 |
Trace the full predicate network for K250080
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.