Multi-Analyte Respiratory Virus Antigen Detection Test
FDA product code SCA · Class II (moderate risk) · 21 CFR 866.3987 · Microbiology
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.
11510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261212 | Flowflex Plus RSV + Flu A/B + COVID Rapid TestSCA · Dual Track | ACON Laboratories, Inc. | 07/10/2026SE |
| K251092 | iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test ProSCA · Traditional | Ihealth Labs, Inc. | 12/12/2025SE |
| K251085 | iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test ProSCA · Traditional | Ihealth Labs, Inc. | 12/12/2025SE |
| K251538 | Status COVID-19/Flu A&BSCA · Dual Track | Princeton BioMeditech Corp. | 11/14/2025SE |
| K251749 | Flowflex Plus RSV + Flu A/B + COVID Home TestSCA · Traditional | ACON Laboratories, Inc. | 10/22/2025SE |
| K251604 | CareSuperb COVID-19/Flu A&B Antigen Combo Home TestSCA · Traditional | Access Bio, Inc. | 08/22/2025SE |
| K251563 | WELLlife Flu A&B Home Test; WELLlife Influenza A&B TestSCA · Traditional | Wondfo USA Co, Ltd. | 08/20/2025SE |
| K243561 | Nano-Check Influenza+COVID-19 Dual TestSCA · Dual Track | Nano-Ditech Corporation | 06/17/2025SE |
| K250377 | Flowflex Plus COVID-19 + Flu A/B Home TestSCA · Traditional | ACON Laboratories, Inc. | 05/10/2025SE |
| K243256 | WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B…SCA · Traditional | Wondfo USA Co, Ltd. | 01/16/2025SE |
| K243262 | QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro TestSCA · Traditional | Osang, LLC | 01/13/2025SE |