ORA

Breast Milk-Alcohol Test System

Product code

ORA

Device name

Breast Milk-Alcohol Test System

Device class

Class 2

21 CFR

21 CFR 862.3040

Medical specialty

Clinical Toxicology

Marketing pathway

510(K)

FDA classification definition

Is intended for use by consumers at home as a qualitative test to identify the presence of alcohol in breast milk.

Definition text from the FDA device classification database (U.S. federal government work, public domain).