# QIAGEN GmbH

- Location (FDA's records): Hilden, DE
- FDA decisions: 29 (1988–2026): 17 510(k) clearances, 1 De Novo grant and 11 original PMA approvals
- Names in FDA's records: QIAGEN GmbH (22); Qiagen, Inc. (5); Qiagen (2)
- Product codes: OWD (7), PCH (5), QOF (3), PSU (2), OCC (2), MAQ (1), PAB (1), OOI (1), OZN (1), PLO (1), OQO (1), NCD (1)
- 510(k) review time since 2016: median 89 days, against 147 for FDA's reviews in the same codes and years (4 of 9 faster)
- Predicates its devices cite: 21 (10 its own); citations of its devices by later devices: 12 (10 its own)
- Recalls linked to its devices: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biofire Diagnostics, LLC: 4 (https://510kreport.com/company/biofire-diagnostics)
- Genmark Diagnostics, Incorporated: 3 (https://510kreport.com/company/genmark-diagnostics)
- Abbott Molecular, Inc.: 1 (https://510kreport.com/company/abbott-molecular)
- Quidel Corp.: 1 (https://510kreport.com/company/quidel)
- Gen-Probe Prodesse, Inc.: 1 (https://510kreport.com/company/gen-probe-prodesse)
- Eragen Biosciences: 1 (https://510kreport.com/company/eragen-biosciences)

## Firms that cite its devices most
- Focus Diagnostics, Inc.: 1 (https://510kreport.com/company/focus-diagnostics)
- Cepheid: 1 (https://510kreport.com/company/cepheid)

## Its most-cited devices
- K220062: QIAstat-Dx Gastrointestinal Panel 2 (2024), cited by 3
- K233100: QIAstat-Dx® Respiratory Panel Plus (2024), cited by 3
- DEN160028: ipsogen JAK2 RGQ PCR Kit (2017), cited by 1
- K250324: QIAstat-Dx GI Panel 2 Mini B (2025), cited by 1
- K242353: QIAstat-Dx Respiratory Panel Mini (2024), cited by 1
- K252329: QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B (2025), cited by 1

## Recent decisions
- K262168: QIAstat-Dx BCID GN Plus AMR Panel (Sep 24, 2026)
- K254194: QIAstat-Dx BCID GPF Plus AMR Panel (Aug 6, 2026)
- K254032: QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B (Mar 9, 2026)
- K252329: QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B (Oct 22, 2025)
- K250080: QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini (Aug 27, 2025)
- K250324: QIAstat-Dx GI Panel 2 Mini B (Feb 28, 2025)
- K243813: QIAstat-Dx GI Panel 2 Mini B&V (Jan 8, 2025)
- K242256: QIAstat-Dx Meningitis/Encephalitis (ME) Panel (Oct 29, 2024)

Source page: https://510kreport.com/company/qiagen