# K250205: Babio® Virus Transport Kit (Non-inactivating)

- Pathway: 510(k) (Traditional)
- Applicant: Jinan Babio Biotechnology Co., Ltd.
- Decided: Sep 22, 2025 after 241 days
- Product code: JSM (Culture Media, Non-Propagating Transport)
- Device class: 1
- Regulation: 21 CFR 866.2390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Babio Virus Transport Kit (Non-inactivating) is intended for the collection and transportation of clinical specimens for preservation of viral agents including Influenza A, Herpes Simplex Virus-1, and Adenovirus from the collection site to the testing laboratory. The Babio Virus Transport Kit contains a culture-based medium that is intended to be used for standard laboratory procedures of virus culture and diagnostic assays which utilize stable recoverable infectious viral particles.

Source page: https://510kreport.com/device/K250205
Methodology: https://510kreport.com/methodology