# K231027: KaiBiLi Extended ViralTrans

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.
- Decided: Dec 21, 2023 after 254 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
Longest line of descent: 2 generations back to K910526 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042970: Copan Universal Transport Medium (Utm-RT) System, Copan Diagnostics, Inc. (2004) Summary page 4.

## Indications for use
The KaiBiLi Extended ViralTrans is intended for the collection and transportation of clinical specimens containing viruses, chlamydiae, mycoplasmas and ureaplasmas from the collection site to the test site. The KaiBiLi Extended ViralTrans is a culture-based medium that has been validated with multiple sample types and can be used to process clinical specimens using standard laboratory operating procedures for culture of clinical specimens or with other assays that utilize stable recoverable infectious viral particles or bacteria.

Source page: https://510kreport.com/device/K231027
Methodology: https://510kreport.com/methodology