Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Jilin.
- Dirui Industrial Co., Ltd. Jilin, contract manufacturer
What Is FDA Product Code CEX?
Chromatographic Separation, Lactate Dehydrogenase Isoenzymes is FDA product code CEX, Class 2, 21 CFR 862.1445.
How Does It Reach the US Market?
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.
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