SCA
- 产品代码
- SCA
- 器械名称
- Multi-Analyte Respiratory Virus Antigen Detection Test
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 866.3987
- FDA 专业组
- Microbiology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 12 件
- 其中 Summary 已存档
- 8 份，可直接下载
- FDA 历史累计 510(k)
- 12 件（全部年份；本站只收录近三年的明细）
FDA 分类定义
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.
该代码近三年的 510(k)（12 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K261212 | 2026-07-10 | ACON Laboratories, Inc. | Flowflex Plus RSV + Flu A/B + COVID Rapid Test | — |
| K251085 | 2025-12-12 | Ihealth Labs, Inc. | iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu… | |
| K251092 | 2025-12-12 | Ihealth Labs, Inc. | iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B… | |
| K251538 | 2025-11-14 | Princeton BioMeditech Corp. | Status COVID-19/Flu A&B | |
| K251749 | 2025-10-22 | ACON Laboratories, Inc. | Flowflex Plus RSV + Flu A/B + COVID Home Test | — |
| K251604 | 2025-08-22 | Access Bio, Inc. | CareSuperb COVID-19/Flu A&B Antigen Combo Home Test | |
| K251563 | 2025-08-20 | Wondfo USA Co, Ltd. | WELLlife Flu A&B Home Test; WELLlife Influenza A&B T… | |
| K243561 | 2025-06-17 | Nano-Ditech Corporation | Nano-Check Influenza+COVID-19 Dual Test | |
| K250377 | 2025-05-10 | ACON Laboratories, Inc. | Flowflex Plus COVID-19 + Flu A/B Home Test | — |
| K243256 | 2025-01-16 | Wondfo USA Co, Ltd. | WELLlife COVID-19 / Influenza A&B Home Test; WELLli… | |
| K243262 | 2025-01-13 | Osang, LLC | QuickFinder COVID-19/Flu Antigen Self Test / QuickFi… | |
| DEN240029 | 2024-10-07 | Healgen | Healgen Rapid Check COVID-19/Flu A&B Antigen Test | — |
FDA 官方分类页： SCA
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。