FDA 510(k)

WELLlife COVID-19 抗原檢測藥品許可證

K 號：K251289 · 2025-10-22

決定日期2025-10-22

產品代碼QVF

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

WELLlife COVID-19 Antigen Test Rx is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2025-10-22 under 510(k) number K251289. The device is classified under product code QVF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the WELLlife COVID-19 Antigen Test Rx?

WELLlife COVID-19 Antigen Test Rx is a medical device that received FDA 510(k) clearance on 2025-10-22. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K251289.

When did WELLlife COVID-19 Antigen Test Rx receive FDA 510(k) clearance?

WELLlife COVID-19 Antigen Test Rx received FDA 510(k) clearance on 2025-10-22, under 510(k) number K251289.

Who is the listed applicant for WELLlife COVID-19 Antigen Test Rx?

The FDA 510(k) record lists Guangzhou Wondfo Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WELLlife COVID-19 Antigen Test Rx?

The FDA product code for WELLlife COVID-19 Antigen Test Rx is QVF.

其他以 Guangzhou Wondfo Biotech Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260065SAFElife T-Dip 多藥尿液檢測組合；SAFElife T-Dip 多藥尿液檢測組合 Dx K252550SAFElife T-Cup 多藥尿液檢測杯；SAFElife T-Cup 多藥尿液檢測杯 Dx K241317Wondfo 2019-nCoV 抗原檢測（橫向流測試法）K241741SAFElife™ 藥物尿檢測儀（試劑條）；SAFElife™ 藥物（FTY）尿檢測試劑條；SAFElife™ T-Dip 藥物尿檢測儀（滴測卡）；SAFElife™ T-Dip 藥物（FTY）尿檢測試劑板 K202567Wondfo T-Dip 多藥尿液檢測組合，Wondfo T-Dip 多藥尿液檢測組合 Rx K182701Wondfo T-Cup 多藥尿液檢測杯

查看所有 10 項裝置 →

相關器械（代碼：QVF）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K254264Sofia 2 SARS 抗原+ FIA；Sofia 2 犬纏虫 FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho)K253882CorDx Tyfast COVID-19 Ag 快速檢測藥品許可證CorDx, Inc.K243872BD Veritor 系統快速檢測 SARS-CoV-2Becton, Dickinson and Company K250273BinaxNOW COVID-19 抗原卡Abbott Diagnostics Scarborough, Inc.K233358SCoV-2 抗原檢測快速檢測試劑InBios International, Inc.K232377Healgen 快速 COVID-19 抗原檢測Healgen Scientific,, LLC

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。