Fluid, Bouin’S

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are based in Guangdong and Shandong: 2 hold an FDA registration.

Jinan Babio Biotechnology Co., Ltd. Shandong
Miraclean Technology Co., Ltd. Guangdong

What Is FDA Product Code IGN?

Fluid, Bouin’S is FDA product code IGN, Class 1, 21 CFR 864.4010.

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. It is also exempt from most of the quality system regulation.

Fluid, Bouin'S

Rowley Biochemical Jax Bouins

Jax Bouin's

Fluid, Bouin'S

Epredia

Bouin’s Fluid is used as a primary fixative or as a mordant when doing special stains such as Masson’s Trichrome.

Fluid, Bouin'S

Fisherbrand

Bouins Fluid Fixative 1GAL

Fluid, Bouin'S

Rowley Biochemical Alcoholic Bouin’s Fluid

Alcoholic Bouin's Fluid

Fluid, Bouin'S

Rowley Biochemical Bouin’s Fluid

Bouin's Fluid

Fluid, Bouin’S

Who Makes This Device Type in China?

What Is FDA Product Code IGN?

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

Rowley Biochemical Jax Bouins

Epredia

Fisherbrand

Rowley Biochemical Alcoholic Bouin’s Fluid

Rowley Biochemical Bouin’s Fluid

Where China Actually Supplies