QIAstat-Dx BCID GN Plus AMR Panel— 510(k) K262168
Substantially EquivalentQIAGEN GmbH
FDA 510(k) clearance K262168 for QIAstat-Dx BCID GN Plus AMR Panel, Substantially Equivalent on 2026-09-24. Applicant: QIAGEN GmbH. Device class: 2.
Summary
The QIAstat-Dx BCID GN Plus AMR Panel is filed under PEN, gram-negative bacteria and associated resistance markers. That code covers multiplexed in vitro diagnostic tests that detect and identify gram-negative bacteria and resistance markers in positive blood cultures. "AMR" in the name refers to antimicrobial resistance. The record doesn't list the organisms or resistance markers on the panel.
Class II, 21 CFR 866.3365, Microbiology panel, Traditional 510(k).
QIAGEN GmbH filed from Hilden, Germany. Review took 90 days (June 26 to September 24, 2026).
Clearance details
- Applicant
- QIAGEN GmbH
- Product code
- Product code PEN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3365
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hilden, DE
Recent devices under product code PEN
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- K213236 — ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
- K193519 — BioFire Blood Culture Identification 2 (BCID2) Panel
- K190341 — iC-GN iC-Cassette for use on the iC-System
More clearances from QIAGEN GmbH
view all- K254194 — QIAstat-Dx BCID GPF Plus AMR Panel
- K254032 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V
- K252329 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V
- K250080 — QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini
- K250324 — QIAstat-Dx GI Panel 2 Mini B
Adverse events under product code PEN
product code PEN- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.