Microtitrator, for Clinical Use
Which Manufacturers in China Make This?
One manufacturer in China holds an FDA registration for this device type, based in Shanghai.
- Shanghai Gene Era Bio-Science Co., Ltd. Shanghai, contract manufacturer
What Is FDA Product Code JRA?
Microtitrator, For Clinical Use is FDA product code JRA, Class 1, 21 CFR 862.2680.
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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