Identifiers
- 510(k) Number
- K141931 FDA 510(k)
- FDA Product Code
- OCC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3980 FDA 510(k)
- Regulation Number
- 866.3980 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Lyra Adenovirus Assay is a real-time PCR in vitro diagnostic assay for the detection of human adenovirus (HAdV) viral DNA. It is designed for qualitative detection of HAdV viral DNA isolated from nasal/nasopharyngeal swabs obtained from patients with respiratory infections.
This assay is part of the Lyra real-time PCR assays, which provide an open platform solution for high throughput, high quality molecular testing to detect and identify infectious diseases. The device is authorized as FDA 510(k) cleared with K number K141931 and is classified as a Class 2 device under product code OCC for respiratory virus panel nucleic acid assay systems.
Frequently asked questions
What is the Lyra Adenovirus Assay used for?
The Lyra Adenovirus Assay is a real-time PCR in vitro diagnostic assay designed for the qualitative detection of human adenovirus (HAdV) viral DNA from nasal/nasopharyngeal swabs obtained from patients with respiratory infections.
How is the Lyra Adenovirus Assay supplied?
The assay is supplied as part of the Lyra real-time PCR assays, which provide an open platform solution for high throughput, high quality molecular testing to detect and identify infectious diseases.
What is the regulatory status of the Lyra Adenovirus Assay?
The device is authorized as FDA 510(k) cleared with K number K141931 and is classified as a Class 2 device under product code OCC for respiratory virus panel nucleic acid assay systems.
What samples can be used with the Lyra Adenovirus Assay?
The assay is designed for qualitative detection of HAdV viral DNA isolated from nasal/nasopharyngeal swabs obtained from patients with respiratory infections.
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: LYRA™ Adenovirus Assay | QuidelOrtho, LYRA™ Adenovirus Assay | QuidelOrtho, Quidel™ Lyra Adenovirus Molecular Assay - Fisher Sci, Quidel Lyra® - Cardinal Health, LYRA ADENOVIRUS ASSAY (K141931) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141931 | Class II | Active |
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Manufacturer
- Manufacturer
- Quidel Corporation
Sources (1)
- FDA 510(k) K141931 24 fields · synced Sep 26, 2026