Control, Fecal Occult Blood

What Is This Device?

Fecal occult blood controls (Negative and positive) are used to verify the performance of the fecal occult blood test devices.

What Is FDA Product Code OSL?

Control, Fecal Occult Blood is FDA product code OSL, Class 2, 21 CFR 864.6550.

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.