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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 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.

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. 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.

Related Devices (Code: JSM)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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