FDA 510(k)

病毒傳播培養基

K 號：K233534 · 2024-08-02

決定日期2024-08-02

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

Viral Transport Medium is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Diagnostics. It received FDA 510(k) clearance on 2024-08-02 under 510(k) number K233534. 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 Viral Transport Medium?

Viral Transport Medium is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Hardy Diagnostics. The 510(k) number is K233534.

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

Viral Transport Medium received FDA 510(k) clearance on 2024-08-02, under 510(k) number K233534.

Who is the listed applicant for Viral Transport Medium?

FDA 510(k) 記錄將 Hardy Diagnostics 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Viral Transport Medium?

The FDA product code for Viral Transport Medium is JSM.

其他以 Hardy Diagnostics 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。

K262113HardyDisk AST 蓋培南 10µg (TBP10)K260842HardyDisk AST Gepotidacin 10µg (GEP10)K253105HardyDisk AST 萬古霉素 30µg (FDC30)K250956HardyDisk AST Gepotidacin 10µg (GEP10)K250454HardyDisk 阿茲特隆胺/阿維巴坦 30/20µg (AZA50)K241060HardyDisk AST 萬古霉素 30µg (FDC30)

查看所有 23 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.K242576AllTest 病毒傳播中間體Hangzhou AllTest Biotech Co., Ltd.K232565UriSponge™Copan Italia Spa K220908Ensol EnTM 样本收集及運輸系統Ensol Biosciences, Inc.K240235OmniTrans 輸送系統Shenzhen Dakewe Bio-Engineering Co., Ltd.

官方來源

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