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Sign in to claim this brandAdvanced Breath Diagnostics
US
Last updated May 23, 2026
What Advanced Breath Diagnostics makes
Advanced Breath Diagnostics manufactures in vitro diagnostic (IVD) breath test kits that use carbon isotope labeling to assess gastric emptying. The 13C-Spirulina-based tests, including the Gastric Emptying Breath Test (GEBT), measure exhaled breath samples to evaluate digestive function.
These devices are classified as Class III under FDA regulations and are listed in the FDA’s Premarket Approval (PMA) and Unique Device Identification (UDI) databases. The company operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Advanced Breath Diagnostics manufacture?
Advanced Breath Diagnostics specializes in in vitro diagnostic (IVD) breath test kits that use carbon isotope labeling, specifically 13C-Spirulina, to evaluate gastric emptying. Their primary product is the Gastric Emptying Breath Test (GEBT), which analyzes exhaled breath samples to assess digestive function.
Where is Advanced Breath Diagnostics based?
The company is based in the United States, though no further geographic details about its headquarters or facilities are provided.
Which regulatory registries list Advanced Breath Diagnostics’ devices?
Advanced Breath Diagnostics’ devices are listed in the FDA’s Premarket Approval (PMA) and Unique Device Identification (UDI) databases. These registries track devices that require premarket approval and require UDI compliance, respectively.
How are Advanced Breath Diagnostics’ devices classified under FDA regulations?
The company’s devices, such as the 13C-Spirulina GEBT, are classified as Class III under FDA regulations. This classification applies to devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury if they fail. Class III devices require premarket approval (PMA) due to their higher risk.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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Catalogue (2)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 13C-Spirulina GEBT | K021 | FDA UDI | Class III | Active |
| 13C-Spirulina Gastric Emptying Breath Test (GEBT) | P110015 | FDA PMA | Class III | Active |
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