QIAstat-Dx Gastrointestinal Panel 2
FDA 510(k)Class II (US FDA 510(k))
by QIAGEN GmbH
Identifiers
- 510(k) Number
- K252329 FDA 510(k)
- FDA Product Code
- PCH FDA 510(k)
- Models / Variants
- QIAstat-Dx Gastrointestinal Panel 2 FDA 510(k)QIAstat-Dx GI Panel 2 Mini B&V FDA 510(k)QIAstat-Dx GI Panel 2 Mini B FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3990 FDA 510(k)
- Regulation Number
- 866.3990 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The QIAstat-Dx Gastrointestinal Panel 2 is a Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System. It is used for the analysis of gastrointestinal infections. The device is a closed, single-use system that contains all reagents needed for sample preparation and multiplex real-time RT-PCR. The QIAstat-Dx GI Panel 2 Mini B&V Cartridge is a component of this system.
The QIAstat-Dx Gastrointestinal Panel 2 is supplied as a single-use device and is used with the QIAstat-Dx Analyzer 2.0 or QIAstat-Dx Rise. It is designed to analyze preserved stool samples and provides comprehensive coverage of clinically-actionable pathogens. The device has been cleared by the FDA and is classified as a Class 2 device with the regulation number 866.3990.
Frequently asked questions
What is the QIAstat-Dx Gastrointestinal Panel 2 used for?
The QIAstat-Dx Gastrointestinal Panel 2 is used for the analysis of gastrointestinal infections, providing comprehensive coverage of clinically-actionable pathogens.
Is the QIAstat-Dx GI Panel 2 a single-use device?
Yes, the QIAstat-Dx Gastrointestinal Panel 2 is supplied as a single-use device, containing all reagents needed for sample preparation and multiplex real-time RT-PCR.
What type of samples can be analyzed with the QIAstat-Dx GI Panel 2?
The QIAstat-Dx Gastrointestinal Panel 2 is designed to analyze preserved stool samples.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Fast panel test for gastrointestinal infections | QIAGEN, HB-3601-004_R4_QIAstatDx_GI2_MiniB&V_0326_US - QIAGEN, QIAGEN QIAstat-Dx® - Cardinal Health, QIAGEN secures U.S. clearance for first QIAstat-Dx mini ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252329 | Class II | Active |
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Manufacturer
- Manufacturer
- QIAGEN GmbH
Sources (1)
- FDA 510(k) K252329 24 fields · synced Oct 1, 2026