BD Veritor System Flu A+B Assay
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K132693 FDA 510(k)
- FDA Product Code
- PSZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3328 FDA 510(k)
- Regulation Number
- 866.3328 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD Veritor System Flu A+B Assay is a rapid diagnostic device designed for the detection of influenza A and B viruses. Classified under the nomenclature for devices detecting influenza antigens, it provides point-of-care testing to identify viral infections in clinical settings.
This assay is intended for single-use in laboratory or point-of-care environments, with no indication of MRI compatibility. Supplied as a CLIA-waived kit, it requires no formal laboratory certification. The device holds FDA 510(k) clearance under Special Review (K132693) and is regulated under FDA classification II (PSZ). Storage and handling follow standard infectious disease protocols.
Frequently asked questions
What clinical setting is the BD Veritor System Flu A+B Assay designed for, and what type of certification is required to use it?
The BD Veritor System Flu A+B Assay is designed for use in both laboratory and point-of-care environments to rapidly detect influenza A and B viruses. Since it is classified as a CLIA-waived kit, no formal laboratory certification is required, making it accessible for settings like clinics, urgent care centers, or physician offices where rapid diagnostic testing is needed.
Is the BD Veritor System Flu A+B Assay intended for single-use or reusable applications, and how should it be handled?
The BD Veritor System Flu A+B Assay is explicitly intended for single-use only, meaning each test kit should not be reused after a single procedure. Handling follows standard infectious disease protocols to ensure safety, as it detects viral antigens that require careful containment and disposal.
What regulatory pathway was followed for FDA clearance of the BD Veritor System Flu A+B Assay, and what classification does it hold?
The BD Veritor System Flu A+B Assay received FDA clearance through a 510(k) submission (K132693) under Special Review, classified as a Class II device (PSZ). This pathway confirms its equivalence to a predicate device and ensures compliance with FDA standards for diagnostic testing of influenza antigens.
Are there specific storage requirements or considerations for the BD Veritor System Flu A+B Assay, and does it have any compatibility restrictions?
While the device data does not specify exact storage conditions, standard infectious disease protocols should be followed to maintain its integrity. There is no indication of MRI compatibility, meaning it should not be used in MRI environments, and it is intended solely for diagnostic testing in clinical or point-of-care settings.
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: BD Veritor™ Plus System for Rapid Detection of Flu A+B, BD Veritor™ System for Rapid Detection of Flu A+B (CLIA-Waived Kit), BD (company) - Wikipedia, BD Veritor™ Plus System for Rapid Detection of Flu A+B
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132693 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K132693 24 fields · synced Sep 18, 2026