← Product Code [SCA](/productcode/SCA) · K261212

# Flowflex Plus RSV + Flu A/B + COVID Rapid Test (K261212)

_ACON Laboratories, Inc. · SCA · Jul 10, 2026 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K261212

## Device Facts

- **Applicant:** ACON Laboratories, Inc.
- **Product Code:** [SCA](/productcode/SCA.md)
- **Decision Date:** Jul 10, 2026
- **Decision:** SESE
- **Submission Type:** Dual Track
- **Regulation:** 21 CFR 866.3987
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Regulatory Identification

A multi-analyte respiratory virus antigen detection test is an in vitro diagnostic device intended for the detection and/or differentiation of respiratory viruses directly from respiratory clinical specimens. The device is intended to be performed at the site of sample collection, does not involve sample storage and/or transport.

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**Source:** [https://fda.innolitics.com/device/K261212](https://fda.innolitics.com/device/K261212)

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