Antigens, Ha (Including Ha Control), Influenza Virus A, B, C
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Zhejiang. All of them are contract manufacturers, able to build to a buyer’s own specification.
- Hangzhou Rollmed Co., Ltd. Zhejiang, contract manufacturer
How Is GNT Classified?
Antigens, Ha (Including Ha Control), Influenza Virus A, B, C is FDA product code GNT, Class 1, 21 CFR 866.3330.
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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