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Sign in to claim this brandMetabolic Solutions, Inc.
United States·US-MF-000032479
Last updated May 23, 2026
What Metabolic Solutions, Inc. makes
Metabolic Solutions, Inc. manufactures the EZ-HBT Helicobacter blood test, a diagnostic device designed to detect Helicobacter pylori infection in blood samples.
The company’s portfolio is regulated under FDA Class I devices and is listed via the 510(k) pathway. The manufacturer is based in 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 Metabolic Solutions, Inc. manufacture?
Metabolic Solutions, Inc. specializes in diagnostic devices, specifically the EZ-HBT Helicobacter blood test. This device is designed to detect Helicobacter pylori infections in blood samples, helping to identify the presence of this bacterium in patients.
Where is Metabolic Solutions, Inc. based?
Metabolic Solutions, Inc. is headquartered in the United States. The company’s location ensures compliance with U.S. regulatory standards for medical devices.
How are the devices manufactured by Metabolic Solutions, Inc. classified under FDA regulations?
The devices produced by Metabolic Solutions, Inc., including the EZ-HBT Helicobacter blood test, fall under FDA Class I classification. This classification is typically assigned to devices posing minimal risk to patients, such as simple diagnostic tools or devices with no direct patient contact that do not significantly affect patient health.
Which regulatory registries or pathways are used to list the devices made by Metabolic Solutions, Inc.?
The devices from Metabolic Solutions, Inc. are listed via the FDA’s 510(k) pathway. This pathway is used for devices that are not new but are substantially equivalent to legally marketed devices, ensuring they meet safety and effectiveness standards before entering the market.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 5450 Quam Ave NE, Suite 100, St. Michael, United States
- Website
- gtmetabolic.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Lisa Griffin Vincent
- EUDAMED SRN
- US-MF-000032479
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (14)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| GT Metabolic Laparoscopic Positioning Device | PD-18 | EUDAMEDFDA UDI | Class I | Active |
| GT Metabolic Laparoscopic Positioning Device | PD-21 | EUDAMEDFDA UDI | Class I | Active |
| GT Metabolic Laparoscopic Positioning Device | PD-27 | EUDAMEDFDA UDI | Class I | Active |
| GT Metabolic Instrument Set | IS-01 | FDA UDI | Class I | Active |
| GT Metabolic DI Magnet - 40mm | MAG-01 | FDA UDI | Class II | Active |
| GT Metabolic Delivery System | DS-01 | FDA UDI | Class II | Active |
| GT Metabolic DI Magnet - 50mm | MAG-02 | FDA UDI | Class II | Active |
| GT Metabolic Laparoscopic Positioning Device | PD-24 | EUDAMEDFDA UDI | Class I | Active |
| GT Metabolic Magnetic Retrieval Device (MRD) | MRD-02 | FDA UDI | Class II | Active |
| GT Metabolic Laparoscopic Positioning Device | PD-12 | EUDAMEDFDA UDI | Class I | Active |
| MagDI System (MAG-01, DS-01) | K242086 | FDA 510(k) | Class II | Active |
| MagDI System | DEN240013 | FDA 510(k) | Class II | Active |
| Ez-Hbt Helicobacter Blood Test | K990931 | FDA 510(k) | Class I | Active |
| MagDI System (MAG-02, DS-01) | K243359 | FDA 510(k) | Class II | Active |
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