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Sign in to claim this brandWhat Genetic Signatures Limited makes
Genetic Signatures Limited produces nucleic acid extraction and isolation kits designed for in vitro diagnostic (IVD) use, as well as controls and detection kits for multiple gastrointestinal pathogens. Their portfolio includes sample processing solutions and PCR-positive controls for identifying gastrointestinal parasites. The company also offers a detection kit specifically for gastrointestinal pathogens, supporting laboratory testing workflows.
The company’s devices are classified as Class II under regulatory frameworks, with submissions listed in the FDA’s 510(k) and Unique Device Identification (UDI) systems. These products are intended for use in the United States, where they are subject to FDA oversight for diagnostic performance and safety. No additional regulatory bodies or international listings are referenced in the provided data.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- geneticsignatures.com
- —
- —
- [email protected]
- Phone
- +61298707580
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 741249601
Catalogue (4)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| EasyScreen™ Gastrointestinal Parasite PCR Positive Control | 1 | FDA UDI | Class II | Active |
| EasyScreen™ Sample Processing Kit | 1 | FDA UDI | N/A | Active |
| EasyScreen™ Sample Processing Kit | 1 | FDA UDI | N/A | Active |
| EasyScreen Gastrointestinal Parasite Detection Kit | K232672 | FDA 510(k) | Class II | Active |
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