Azan Counterstain
Which Manufacturers in China Make This?
One manufacturer in China holds an FDA registration for this device type, based in Hubei.
How Is ICT Classified?
Azan Counterstain is FDA product code ICT, Class 1, 21 CFR 864.1850.
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. It is also exempt from most of the quality system regulation.
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