Analyzer, Enzyme, for Clinical Use
Who Makes This Device Type in China?
3 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Shanghai and Zhejiang.
- Aikang Medtech Co., Ltd. Guangdong
- Shanghai Kehua Laboratory System Co., Ltd. Shanghai
- Zhejiang Orient Gene Biotech Zhejiang, contract manufacturer
How Is JJI Classified?
Analyzer, Enzyme, For Clinical Use is FDA product code JJI, Class 1, 21 CFR 862.2500.
What Does It Take to Sell It in the United States?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.
What Do the Recalls Say?
The FDA has recorded 1 recall under this product code since 2007. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
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