QIAGEN GmbH - FDA 510(k) Cleared Devices

Cleared Sep 24, 2026

QIAstat-Dx BCID GN Plus AMR Panel

K262168 · PEN

Microbiology · 90d

Cleared Aug 06, 2026

QIAstat-Dx BCID GPF Plus AMR Panel

K254194 · PAM

Microbiology · 226d

Cleared Mar 09, 2026

QIAstat-Dx Gastrointestinal Panel 2

K254032 · PCH

Microbiology · 83d

Cleared Oct 22, 2025

QIAstat-Dx Gastrointestinal Panel 2

K252329 · PCH

Microbiology · 89d

Cleared Aug 27, 2025

QIAstat-Dx Respiratory Panel Plus

K250080 · QOF

Microbiology · 226d

Cleared Feb 28, 2025

QIAstat-Dx GI Panel 2 Mini B

K250324 · PCH

Microbiology · 23d

Cleared Jan 08, 2025

QIAstat-Dx GI Panel 2 Mini B&V

K243813 · PCH

Microbiology · 28d

Cleared Oct 29, 2024

QIAstat-Dx Meningitis/Encephalitis (ME) Panel

K242256 · PLO

Microbiology · 90d

Cleared Oct 25, 2024

QIAstat-Dx Respiratory Panel Mini

K242353 · QOF

Microbiology · 78d

Cleared May 31, 2024

QIAstat-Dx Gastrointestinal Panel 2

K220062 · PCH

Microbiology · 872d

Cleared May 10, 2024

QIAstat-Dx® Respiratory Panel Plus

K233100 · QOF

Microbiology · 227d

Cleared May 18, 2019

QIAstat-Dx Respiratory Panel

K183597 · OCC

Microbiology · 148d