Is this your brand? Sign in to claim ownership.
Sign in to claim this brandGenomadix, Inc.
US
Last updated May 30, 2026
What Genomadix, Inc. makes
Genomadix, Inc. manufactures nucleic acid amplification mastermix kits designed for in vitro diagnostic use, as well as oral and upper respiratory tract specimen collection swabs for sample collection. Their portfolio also includes thermal cycler systems for laboratory-based nucleic acid amplification analysis, specifically the Genomadix Cube CYP2C19 System.
The company’s devices are classified as Class II under regulatory frameworks, with authorisations listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These products are intended for use in the United States, where the manufacturer is based.
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 Genomadix, Inc. manufacture?
Genomadix, Inc. specializes in in vitro diagnostic (IVD) devices. Their portfolio includes nucleic acid amplification mastermix kits, which are used to amplify DNA or RNA for analysis, oral/upper respiratory tract specimen collection swabs for gathering biological samples, and thermal cycler systems like the Genomadix Cube CYP2C19 System. These devices are designed for laboratory use to detect, analyze, or monitor genetic or infectious markers.
Where is Genomadix, Inc. based, and where are their devices intended for use?
Genomadix, Inc. is headquartered in the United States. Their devices are specifically intended for use within the U.S. regulatory environment, where they are authorized under applicable frameworks. The company’s focus aligns with U.S. market needs for diagnostic tools.
Which regulatory registries list Genomadix, Inc.’s devices?
Genomadix, Inc.’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries track devices that have undergone the necessary regulatory pathways to demonstrate safety and effectiveness for their intended use, ensuring transparency and compliance.
How are Genomadix, Inc.’s devices classified under regulatory frameworks?
Genomadix, Inc.’s devices fall under Class II classification in regulatory frameworks. This classification applies to devices that generally pose moderate risk and require special controls beyond general controls to ensure their safety and performance. Class II devices often require premarket notification (510(k)) to demonstrate substantial equivalence to a predicate device.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- genomadix.com
- —
- —
- [email protected]
- Phone
- 1-888-810-7788
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 204354752
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Genomadix Cube CYP2C19, | 2 | FDA UDI | Class II | Active |
| Genomadix Cube CYP2C19 | 2 | FDA UDI | Class II | Active |
| Genomadix Cube CYP2C19 | 2 | FDA UDI | Class II | Active |
| Genomadix Cube CYP2C19 | 2 | FDA UDI | Class II | Active |
| Genomadix Cube CYP2C19 | 2 | FDA UDI | Class II | Active |
| Genomadix Cube CYP2C19 | 2 | FDA UDI | Class II | Active |
| Genomadix Cube CYP2C19 System | K220026 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Genomadix Inc Kanata (Ottawa) Ontario · CA FEI 3021047648