BD Veritor System for Rapid Detection of Flu A+B
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K132259 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 is a diagnostic device designed for the rapid detection of influenza A and B viruses. Classified under Devices Detecting Influenza A, B, and C Virus Antigens, it provides point-of-care testing to identify viral infections quickly, supporting timely clinical decision-making in microbiology settings.
This system is intended for single-use in clinical laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) as waived. Supplied as a handheld device, it requires no complex setup and delivers results within minutes. The device is regulated under FDA 510(k) clearance (K132259) and adheres to the classification of Class II medical devices, ensuring compliance with U.S. regulatory standards for microbiological testing.
Frequently asked questions
What clinical settings is the BD Veritor System approved for use in, and how quickly can results be obtained?
The BD Veritor System is approved for use in clinical laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) as waived. It is designed for point-of-care testing and delivers results within minutes, enabling rapid detection of influenza A and B viruses to support timely clinical decisions in microbiology settings.
Is the BD Veritor System intended for single-use or repeated use, and how is it supplied?
The BD Veritor System is intended for single-use only. It is supplied as a handheld device, which requires no complex setup, making it convenient for quick and easy use in clinical environments.
What regulatory pathway was followed for the BD Veritor System, and what class of medical device does it fall under?
The BD Veritor System followed the FDA 510(k) clearance pathway, specifically under the classification of Class II medical devices. It was determined to be substantially equivalent to a predicate device and is regulated under the U.S. regulatory standards for microbiological testing, ensuring compliance with the requirements for detecting influenza A, B, and C virus antigens.
Does the BD Veritor System require any special handling or storage conditions?
The device data does not specify special handling or storage conditions, but as a single-use, point-of-care diagnostic tool, it should be stored according to standard medical device guidelines to maintain its integrity and functionality until use. Always refer to the manufacturer’s instructions for precise storage recommendations.
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 Veritor™ Plus System for Rapid Detection of SARS-CoV-2, 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 | K132259 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K132259 24 fields · synced Sep 18, 2026