Hydrazone Colorimetry, Ast/Sgot

Which Manufacturers in China Make This?

One manufacturer in China holds an FDA registration for this device type, based in Guangxi.

Urit Medical Electronic Co., Ltd. Guangxi, contract manufacturer

What Is FDA Product Code CIS?

Hydrazone Colorimetry, Ast/Sgot is FDA product code CIS, Class 2, 21 CFR 862.1100.

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.

Hydrazone Colorimetry, Ast/Sgot

Aspartate Aminotransferase Test Strip

3 catalogue numbers from PS 92.25 strips/vial ×4/box, listed by Urit Medical Electronic Co., Ltd., China, under Hydrazone Colorimetry, Ast/Sgot. 1 manufacturer in China is registered for this product code.

Hydrazone Colorimetry, Ast/Sgot

Aspartate Aminotransferase (AST)

2 catalogue numbers from AS101, listed by Randox Laboratories Limited, United Kingdom, under Hydrazone Colorimetry, Ast/Sgot. 1 manufacturer in China is registered for this product code.

Hydrazone Colorimetry, Ast/Sgot

Which Manufacturers in China Make This?

What Is FDA Product Code CIS?

What Does It Take to Sell It in the United States?

Aspartate Aminotransferase Test Strip

Aspartate Aminotransferase (AST)

Where China Actually Supplies