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BD Veritor System for the Rapid Detection of Flu A+B

FDA 510(k)

Class II (US FDA 510(k))

510(k) K132256

by Becton, Dickinson and Company

Identifiers

510(k) Number
K132256 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 an in vitro 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 antigens in clinical samples, supporting timely diagnostic decisions in microbiology settings.

This system is intended for single-use in laboratory or point-of-care environments, requiring no special sterility conditions beyond standard aseptic handling. It is a Class II device under FDA regulations (866.3328) and has received FDA 510(k) clearance as substantially equivalent to a predicate device. The device operates via a handheld format and is not MRI-compatible; storage and handling follow standard in vitro diagnostic protocols.

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

United States Active

FDA_510K

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Manufacturer

Manufacturer
Becton, Dickinson and Company

Sources (1)

  • FDA 510(k) K132256 24 fields · synced Sep 18, 2026