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FDA 510(k)

AllTest 病毒傳播中間體

K 號：K242576 · 2025-04-04

申請人Hangzhou AllTest Biotech Co., Ltd.
決定日期2025-04-04
產品代碼JSM
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

AllTest Viral Transport Medium is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. It received FDA 510(k) clearance on 2025-04-04 under 510(k) number K242576. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AllTest Viral Transport Medium?

AllTest Viral Transport Medium is a medical device that received FDA 510(k) clearance on 2025-04-04. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K242576.

When did AllTest Viral Transport Medium receive FDA 510(k) clearance?

AllTest Viral Transport Medium received FDA 510(k) clearance on 2025-04-04, under 510(k) number K242576.

Who is the listed applicant for AllTest Viral Transport Medium?

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

What is the FDA product code for AllTest Viral Transport Medium?

The FDA product code for AllTest Viral Transport Medium is JSM.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Hangzhou AllTest 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。

K260342AllTest Strep A Rapid TestK252607AllTest 尿路感染檢測試劑K251053Shinetell Plus™數位早期懷孕檢測器K250727AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupK244043AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupK242540AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel

查看所有 14 項裝置 →

相關器械（代碼：JSM）

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。

K242976醫用針繩糞便轉移液Cary Blair培養基收集及運輸設備Medical Wire & Equipment Company (Bath), Ltd.K250205Babio® 病毒傳送組合包（非失活型）Jinan Babio Biotechnology Co., Ltd.K232565UriSponge™Copan Italia SpaK220908Ensol EnTM 样本收集及運輸系統Ensol Biosciences, Inc.K240235OmniTrans 輸送系統Shenzhen Dakewe Bio-Engineering Co., Ltd.K233534病毒傳播培養基Hardy Diagnostics

官方來源

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