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Flowflex Plus COVID-19 Home Test

by Acon Laboratories, Inc.

510(k) K233373

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK233373 Date19 Apr 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
QYT
Device Class
Class II
Regulation
21 CFR Part 866.3984
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Flowflex Plus COVID-19 Home Test is an over-the-counter rapid antigen test designed for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in nasal swab specimens. It is classified as a Class II device under FDA regulations and intended for home use to aid in the diagnosis of COVID-19 infection by individuals without professional medical training.

This single-use test is supplied as a lateral flow immunoassay kit, requiring no external power or instrumentation. It is intended for use by laypersons and provides results within 15 minutes. The device is not sterile and must be stored at controlled room temperature (15–30°C) until use. Authorized under FDA 510(k) clearance (K233373), it adheres to regulatory standards for over-the-counter COVID-19 antigen tests.

From the manufacturer

ACON Laboratories, Inc. is the only legal manufacturer of the FDA EUA Flowflex COVID-19 Antigen Home Test.

Source: aconlabs.com

Other devices from Acon Laboratories, Inc.

See all devices from Acon Laboratories, Inc. →

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Flowflex Plus COVID-19 Home Test used for?

    This test is designed for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in nasal swab specimens. It aids in diagnosing COVID-19 infection by identifying the presence of the virus, allowing individuals to assess their infection status at home without professional medical training.

  • How is the Flowflex Plus COVID-19 Home Test supplied and how does it work?

    The test is supplied as a single-use lateral flow immunoassay kit, requiring no external power or additional instrumentation. It uses a nasal swab to collect a specimen, which is then processed in the test device. Results appear within 15 minutes, indicated by visual lines on the test cassette.

  • Is the Flowflex Plus COVID-19 Home Test sterile?

    No, the Flowflex Plus COVID-19 Home Test is not sterile. It is intended for one-time use and should be handled with care to avoid contamination. Sterility is not required for over-the-counter rapid antigen tests of this type.

  • Can the Flowflex Plus COVID-19 Home Test be reused?

    No, the test is explicitly designed for single-use only. Reusing the device could compromise accuracy and introduce cross-contamination risks, which is why it is not recommended or supported by the manufacturer.

  • What storage conditions are required for the Flowflex Plus COVID-19 Home Test?

    The test must be stored at controlled room temperature between 15°C and 30°C until use. Avoid exposure to extreme temperatures, direct sunlight, or moisture, as these conditions could affect the test’s performance and validity.