In September 2024, this product obtained a 510k Class II medical device marketing authorization from the US FDA, becoming the first in China and the second globally to achieve this.
It solved the challenge of "ready-to-use" drug formulations for stem cell pharmaceutical companies in clinical hospitals. This product has been selected by multiple pharmaceutical companies and has passed IND approvals from both Chinese and American regulatory authorities.
It is used for automated culture of suspension cells such as NK, CIK, T, 293, and CHO.
It innovatively proposed the approach of "repair before culture," solving the problem of culture failure for a significant proportion of "poor-quality samples" that arises with traditional "direct culture" methods.
The use of disposable consumables greatly reduces production complexity and the rate of contamination incidents during production, significantly lowering manufacturing costs for customers.
