Enzyme Immunoassay, Inhibin-A

Which Manufacturers in China Make This?

2 manufacturers in China hold an FDA registration for this device type, based in Jilin and Shandong.

Biobase Biodustry(Shandong)Co., Ltd. Shandong
Dirui Industrial Co., Ltd. Jilin, contract manufacturer

What Is FDA Product Code NDR?

Enzyme Immunoassay, Inhibin-A is FDA product code NDR, Class 1, 21 CFR 862.1260.

How Does It Reach the US Market?

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.

What Has Gone Wrong With It?

The FDA has recorded 3 recalls under this product code since 2010. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

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