Kit, Mycoplasma Detection
Which Manufacturers in China Make This?
The one Chinese manufacturer registered for this device type is based in Shandong.
- Jinan Babio Biotechnology Co., Ltd. Shandong
How Is KIW Classified?
Kit, Mycoplasma Detection is FDA product code KIW, Class 1, 21 CFR 864.2360.
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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