Quidel Molecular Influenza A + B Assay
FDA 510(k)Class II (US FDA 510(k))
by Quidel Corp.
Identifiers
- 510(k) Number
- K112172 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 Quidel Molecular Influenza A + B Assay is a qualitative in vitro diagnostic test for the detection and differentiation of influenza A and influenza B viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. It is a multiplex Real Time RT-PCR assay.
The assay is supplied for use in microbiology settings and is regulated under the product code OCC, with a regulation number of 866.3980. It has been cleared by the FDA under the traditional clearance type, with a decision code of SESE and a k number of K112172. The device is a Respiratory Virus Panel Nucleic Acid Assay System, classified as a class 2 device.
Frequently asked questions
What is the Quidel Molecular Influenza A + B Assay used for?
The Quidel Molecular Influenza A + B Assay is used for the detection and differentiation of influenza A and influenza B viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection.
How is the Quidel Molecular Influenza A + B Assay supplied?
The assay is supplied for use in microbiology settings.
What type of device is the Quidel Molecular Influenza A + B Assay?
The device is a Respiratory Virus Panel Nucleic Acid Assay System, classified as a class 2 device.
What is the regulatory classification of the Quidel Molecular Influenza A + B Assay?
The assay is regulated under the product code OCC, with a regulation number of 866.3980.
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: SOLANA™ Influenza A+B Assay | QuidelOrtho, QUICKVUE™ Influenza A+B Test | QuidelOrtho, QUIDEL MOLECULAR INFLUENZA A + B ASSAY - Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K112172 | Class II | Active |
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Manufacturer
- Manufacturer
- Quidel Corp.
Sources (1)
- FDA 510(k) K112172 24 fields · synced Sep 21, 2026