FDA product code ORA: Breast Milk-Alcohol Test System
ORA is the FDA product code for breast milk-alcohol test system. It is a Class II device, regulated under 21 CFR 862.3040 and reviewed by the Clinical Toxicology panel. Devices under ORA reach the market by 510(k); FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for ORA devices, 1 initiated in the last five years.
Definition
Is intended for use by consumers at home as a qualitative test to identify the presence of alcohol in breast milk.
Classification
| Field | Value |
|---|---|
| Device name | Breast Milk-Alcohol Test System |
| Device class | Class II |
| Regulation | 21 CFR 862.3040 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
Recalls for ORA devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-05-22.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code ORA?
ORA is the FDA product code for breast milk-alcohol test system. It is a Class II device, regulated under 21 CFR 862.3040 and reviewed by the Clinical Toxicology panel.
What device class is ORA?
Class II, regulation 21 CFR 862.3040. Typical premarket route: 510(k).
Have ORA devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-05-22.
Next steps
- Run an FDA pathway report with predicate devices for product code ORA
- Run a recall and safety report across every ORA manufacturer
- Watch product code ORA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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