QIAstat-Dx Respiratory Panel Mini
FDA 510(k)Class II (US FDA 510(k))
by QIAGEN GmbH
Identifiers
- 510(k) Number
- K242353 FDA 510(k)
- FDA Product Code
- QOF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3981 FDA 510(k)
- Regulation Number
- 866.3981 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The QIAstat-Dx Respiratory Panel Mini is a multi-target respiratory specimen nucleic acid test. It is designed to analyze viral targets for pathogens that cause respiratory symptoms, including SARS-CoV-2 and Human Rhinovirus.
This device is supplied as individually packaged cartridges containing reagents for sample preparation and multiplex RT-real time PCR, along with internal controls and transfer pipettes. The product has received FDA 510(k) clearance.
Frequently asked questions
What is the QIAstat-Dx Respiratory Panel Mini used for?
This device is a multi-target respiratory specimen nucleic acid test. It is specifically designed to analyze viral targets for pathogens that cause respiratory symptoms, including SARS-CoV-2 and Human Rhinovirus.
How is the test supplied to the laboratory?
The product is supplied as individually packaged cartridges. Each cartridge contains the necessary reagents for sample preparation and multiplex RT-real time PCR, along with internal controls and transfer pipettes to facilitate testing.
Has this device received regulatory authorization?
Yes, the QIAstat-Dx Respiratory Panel Mini has received FDA 510(k) clearance. This indicates that the device has been reviewed and found to be substantially equivalent to a legally marketed predicate device.
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: QIAstat-Dx US - QIAGEN, QIAstat-Dx Respiratory Panel | Syndromic Testing | QIAGEN, PDF QIAstat-Dx® Respiratory Panels brochure - Cardinal Health
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242353 | Class II | Active |
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Manufacturer
- Manufacturer
- QIAGEN GmbH
Sources (1)
- FDA 510(k) K242353 24 fields · synced Sep 21, 2026