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QIAGEN GmbH FDA Approvals
0 new drug approvals and 11 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| QIAstat-Dx BCID GN Plus AMR Panel510(k)Sep 24, 2026Microbiology |
| QIAstat-Dx BCID GPF Plus AMR Panel510(k)Aug 6, 2026Microbiology |
| QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B510(k)Mar 9, 2026Microbiology |
| QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B510(k)Oct 22, 2025Microbiology |
| QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini510(k)Aug 27, 2025Microbiology |
| QIAstat-Dx GI Panel 2 Mini B510(k)Feb 28, 2025Microbiology |
| QIAstat-Dx GI Panel 2 Mini B&V510(k)Jan 8, 2025Microbiology |
| QIAstat-Dx Meningitis/Encephalitis (ME) Panel510(k)Oct 29, 2024Microbiology |
| QIAstat-Dx Respiratory Panel Mini510(k)Oct 25, 2024Microbiology |
| QIAstat-Dx Gastrointestinal Panel 2510(k)May 31, 2024Microbiology |
| QIAstat-Dx® Respiratory Panel Plus510(k)May 10, 2024Microbiology |