Multi-analyte Respiratory Virus Antigen Detection Test
Microbiology · 21 CFR 866.3987
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.
Recent MDR events
49 adverse event reports on file
- Flowflex Plus RSV + Flu A/B + COVID Home TestJul 29, 2026MalfunctionAcon Laboratories, Inc.2531491-2026-00158
- Flowflex Plus RSV + Flu A/B + COVID Home TestJul 29, 2026MalfunctionAcon Laboratories, Inc.2531491-2026-00154
- FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TESTJul 9, 2026MalfunctionAcon Laboratories, Inc.2531491-2026-00145
- FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TESTJul 9, 2026MalfunctionAcon Laboratories, Inc.2531491-2026-00148
- IHEALTHJun 22, 2026MalfunctionAndon Medical Co.,ltd3008573045-2026-00006
- FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TESTMay 27, 2026MalfunctionAcon Laboratories, Inc.2531491-2026-00128
- FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TESTMay 27, 2026MalfunctionAcon Laboratories, Inc.2531491-2026-00130
- FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TESTMay 11, 2026MalfunctionAcon Laboratories, Inc.2531491-2026-00120
- FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TESTMay 11, 2026MalfunctionAcon Laboratories, Inc.2531491-2026-00126
- FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TESTApr 30, 2026MalfunctionAcon Laboratories, Inc.2531491-2026-00111
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
32 firms currently registered for this product code
Genabio Diagnostics Inc
Bedford, MA, US
Acon Laboratories, Inc.
SAN DIEGO, CA, US
Medline Industries, Lp - Northfield
Northfield, IL, US
Germaine Laboratories, Inc.
SAN ANTONIO, TX, US
Biohit Healthcare (hefei) Co., Ltd.
Hefei Anhui, CN
Osang Llc
S Pasadena, CA, US
Osang Healthcare Co., Ltd.
ANYANG Gyeonggi, KR
Btnx Inc.
Pickering Ontario, CA
Diversified Synergies, Llc
Detroit, MI, US
Guangzhou Wondfo Biotech Co., Ltd.
Guangzhou Guangdong, CN
Hian (hong Kong) Co., Limited
Hong Kong, HK
Maq-ops, S. De R.l.
Tijuana Baja California, MX
Andon Medical Co., Ltd
Tianjin, CN
Princeton Biomeditech Corp.
Plainsboro, NJ, US
Meridian Bioscience, Inc.
Cincinnati, OH, US
Wondfo Usa Co., Ltd.
San Diego, CA, US
Abbott Diagnostics Scarborough, Inc.
Scarborough, ME, US
Confirm Biosciences Llc
SAN DIEGO, CA, US
Healgen Scientific Llc
Houston, TX, US
Princeton Biomeditech Corp.
Monmouth Jct, NJ, US
Zhejiang Orient Gene Biotech
Huzhou Zhejiang, CN
510(k) clearances
12 clearances for this product code
- ACON Laboratories, Inc.Jul 10, 2026
K261212 · Flowflex Plus RSV + Flu A/B + COVID Rapid Test
- Ihealth Labs, Inc.Dec 12, 2025
K251085 · iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro
- Ihealth Labs, Inc.Dec 12, 2025
K251092 · iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro
- Princeton BioMeditech Corp.Nov 14, 2025
K251538 · Status COVID-19/Flu A&B
- ACON Laboratories, Inc.Oct 22, 2025
K251749 · Flowflex Plus RSV + Flu A/B + COVID Home Test
- Access Bio, Inc.Aug 22, 2025
K251604 · CareSuperb COVID-19/Flu A&B Antigen Combo Home Test
- Wondfo USA Co, Ltd.Aug 20, 2025
K251563 · WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test
- Nano-Ditech CorporationJun 17, 2025
K243561 · Nano-Check Influenza+COVID-19 Dual Test