Flowflex Plus RSV + Flu A/B + COVID Rapid Test
Device Facts
| Record ID | K261212 |
|---|---|
| Device Name | Flowflex Plus RSV + Flu A/B + COVID Rapid Test |
| Applicant | ACON Laboratories, Inc. |
| Product Code | SCA · Microbiology |
| Decision Date | Jul 10, 2026 |
| Decision | SESE |
| Submission Type | Dual Track |
| Regulation | 21 CFR 866.3987 |
| Device Class | Class 2 |
Regulatory Classification
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.
