ORA — Breast Milk-Alcohol Test System Class II
FDA product code ORA covers "Breast Milk-Alcohol Test System", a Class II medical device regulated under 21 CFR 862.3040. Submissions are reviewed by the Clinical Toxicology panel.
Classification Details
- Product Code
- ORA
- Device Class
- Class II
- Regulation Number
- 862.3040
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Definition
Is intended for use by consumers at home as a qualitative test to identify the presence of alcohol in breast milk.