Product code ORA
- Device name
- Breast Milk-Alcohol Test System
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3040
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Is intended for use by consumers at home as a qualitative test to identify the presence of alcohol in breast milk.
- Source
- FDA openFDA device classification dataset