Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4
Which Manufacturers in China Make This?
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
What Is FDA Product Code GQR?
Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4 is FDA product code GQR, Class 1, 21 CFR 866.3400.
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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