Documento fuente o registro público
FDA 510(k) K231027 — KaiBiLi Extended ViralTrans
FDA 510(k) index record K231027. Device: KaiBiLi Extended ViralTrans. Applicant as listed: Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.. Decision date: 2023-12-21.
Fuente
"device_name": "KaiBiLi Extended ViralTrans"
Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.
Review and references
Automated FDA record verification
2026-10-20
2026-10-28
professional use
FDA 510(k) public index record K231027.
Device name: KaiBiLi Extended ViralTrans. Applicant as listed: Hangzhou Genesis Biodetection & Biocontrol Co., Ltd..
Decision date: 2023-12-21. Decision wording: Substantially Equivalent.
Product code: JSM. Regulation: 21 CFR 866.2390. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
Interested in these solutions?
Submit a sourcing request with the assays, volumes, and timeline of your own project.
