In Vitro Diagnostics · IVD Solutions
In Vitro Diagnostic Testing Solutions for the Global Market
Jingzhun Bio focuses on molecular diagnostics for infectious diseases, point-of-care testing (POCT) and lateral-flow immunoassay. We supply products and technical collaboration to distribution, laboratory and healthcare partners worldwide. 165 devices are listed in the Notified Body confirmation letter (TÜV Rheinland, NB 0197), with a transition pathway under Regulation (EU) 2024/1860.
For professional in-vitro diagnostic use only.
What we do
Molecular diagnostics
Built on an isothermal amplification + CRISPR molecular POCT platform, covering respiratory, gastrointestinal, reproductive-tract and tropical-disease pathogen testing.
POCT rapid testing
Isothermal amplification combined with lateral-flow technology covers rapid testing for infectious diseases and key biomarkers; our proprietary RAA + CRISPR molecular POCT platform delivers on-site molecular results in 20–30 minutes.
Global partner services
As master distributor of the Kangsheng Yanxuan system, we provide international distributors and laboratory partners with a supply of 165 authorized products (listed in the NB 0197 confirmation letter), technical training and after-sales collaboration.
EU regulatory pathway
Notified Body TÜV Rheinland LGA Products GmbH (NB 0197) issued a confirmation letter on 10 July 2026: the relevant devices have completed a formal IVDR application with a written agreement in place, and a transition pathway applies under Regulation (EU) 2024/1860 — 88 Class C devices (until 2028-12-31) and 77 Class B devices (until 2029-12-31). Product names are used exactly as they appear in the letter; see the product portfolio.