FDA 510(k)

生物篩多藥尿液檢測組合；生物篩多藥尿液家庭檢測組合

K 號：K261280 · 2026-05-22

申請人Vivachek Biotech (Hangzhou) Co., Ltd.

決定日期2026-05-22

產品代碼NFT

諮詢委員會此醫療器材法規描述涉及FDA、510(k)、PMA、NCT、PMID及相關網址，以下為繁體中文翻譯：本醫療器材之監管狀態係依據美國食品藥物管理局（FDA）之相關規定，包括510(k)上市前通知及PMA上市前核准程序。相關臨床試驗資訊可參閱NCT編號及PMID文獻編號，詳細資料請見所附網址。

決定相當於

器材摘要

BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel is the device name listed in this FDA 510(k) record. The listed applicant is Vivachek Biotech (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2026-05-22 under 510(k) number K261280. The device is classified under product code NFT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel?

BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel is a medical device that received FDA 510(k) clearance on 2026-05-22. The listed applicant is Vivachek Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K261280.

When did BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel receive FDA 510(k) clearance?

BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel received FDA 510(k) clearance on 2026-05-22, under 510(k) number K261280.

Who is the listed applicant for BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel?

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

What is the FDA product code for BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel?

The FDA product code for BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel is NFT.

其他以 Vivachek Biotech (Hangzhou) 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。

K252554Wisdiag 多藥尿液檢測杯；Wisdiag 多藥尿液家庭檢測杯 K241869BioSieve™ 藥物濃度快速檢測 Fentanyl 家庭檢測套件；BioSieve™ 藥物濃度快速檢測 Fentanyl Pro 檢測套件；BioSieve™ Toxismart 閱讀器 K222126VivaChek™ Fad 血糖監測系統，VivaChek™ Fad 智能血糖監測系統，VivaChek™ Fad 同步血糖監測系統 K240124BioSieve™ 藥物濃度快速檢測套件；BioSieve™ ToxiSmart FIA 閱讀器 K233058VivaChek Link Plus 血糖監測系統 K233062BioSieve™ 多藥尿液檢測組合；BioSieve™ 多藥尿液檢測組合 Rx

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相關器械（代碼：NFT）

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。

K261409BioTeke® 多藥尿液檢測杯Bioteke Corporation (Wuxi) Co., Ltd.K261984AssureTech 快速測試杯；AssureTech 多藥尿液測試杯Assure Tech., LLC K260065SAFElife T-Dip 多藥尿液檢測組合；SAFElife T-Dip 多藥尿液檢測組合 DxGuangzhou Wondfo Biotech Co., Ltd.K260355Webest 多藥尿液杯；Webest 家用多藥尿液杯WEBEST Biotech,, LLC K252550SAFElife T-Cup 多藥尿液檢測杯；SAFElife T-Cup 多藥尿液檢測杯 DxGuangzhou Wondfo Biotech Co., Ltd.K252867VINScreen 尿藥檢測杯；VINScreen 尿藥檢測家庭用杯Advin Biotech, Inc.

官方來源

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