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FDA 510(k)

Babio® Virus Transport Kit (Non-inactivating)

K-Number: K250205 · 2025-09-22

ApplicantJinan Babio Biotechnology Co., Ltd.
Decision Date2025-09-22
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Babio® Virus Transport Kit (Non-inactivating) is a medical device manufactured by Jinan Babio Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-22 under approval number K250205. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Jinan Babio Biotechnology Co., Ltd.. The 510(k) number is K250205.

When was Babio® Virus Transport Kit (Non-inactivating) approved by the FDA?

Babio® Virus Transport Kit (Non-inactivating) received FDA 510(k) clearance on 2025-09-22, under approval number K250205.

What company makes Babio® Virus Transport Kit (Non-inactivating)?

Babio® Virus Transport Kit (Non-inactivating) is manufactured by Jinan Babio Biotechnology Co., Ltd..

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.

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Official Source

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