Alpha 2, 2n-Glycoprotein, Antigen, Antiserum, Control
Which Manufacturers in China Make This?
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 DBC?
Alpha 2, 2n-Glycoprotein, Antigen, Antiserum, Control is FDA product code DBC, Class 1, 21 CFR 866.5425.
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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