Antigens, Cf, All, Mycoplasma Spp.
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Guangdong.
How Is GSB Classified?
Antigens, Cf, All, Mycoplasma Spp. is FDA product code GSB, Class 1, 21 CFR 866.3375.
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.
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