Babio® 病毒傳送組合包（非失活型）
K 號：K250205 · 2025-09-22
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器材摘要
Babio® Virus Transport Kit (Non-inactivating) is the device name listed in this FDA 510(k) record. The listed applicant is Jinan Babio Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-22 under 510(k) number K250205. 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 Babio® Virus Transport Kit (Non-inactivating)?
Babio® Virus Transport Kit (Non-inactivating) is a medical device that received FDA 510(k) clearance on 2025-09-22. The listed applicant is Jinan Babio Biotechnology Co., Ltd.. The 510(k) number is K250205.
When did Babio® Virus Transport Kit (Non-inactivating) receive FDA 510(k) clearance?
Babio® Virus Transport Kit (Non-inactivating) received FDA 510(k) clearance on 2025-09-22, under 510(k) number K250205.
Who is the listed applicant for Babio® Virus Transport Kit (Non-inactivating)?
The FDA 510(k) record lists Jinan Babio Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Babio® Virus Transport Kit (Non-inactivating)?
The FDA product code for Babio® Virus Transport Kit (Non-inactivating) is JSM.
相關臨床試驗
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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。
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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。
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