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Sign in to claim this brandWhat SensID GmbH makes
SensID GmbH produces in vitro diagnostic (IVD) kits, specifically exogenous DNA/RNA internal control IVD kits. Examples of their products include the SensID Idylla MSI FFPE Reference Set, which is used for molecular testing. These kits are designed for use in laboratory settings and are used to control the quality of DNA/RNA testing.
The company's portfolio is regulated as Class II devices and is listed in the FDA's UDI registry. The devices are subject to regulatory oversight, ensuring they meet certain standards for safety and effectiveness. SensID GmbH is based in the US, where its devices are manufactured and distributed.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What type of products does SensID GmbH manufacture?
SensID GmbH manufactures in vitro diagnostic (IVD) kits, specifically exogenous DNA/RNA internal control IVD kits. These products are designed for laboratory use to control the quality of DNA/RNA testing, such as the SensID Idylla MSI FFPE Reference Set, which supports molecular testing applications.
Where is SensID GmbH based?
SensID GmbH is based in the United States, where its devices are manufactured and distributed. The company’s location in the US is specified in the provided data, and this is where its operations for producing and supplying its IVD kits are located.
In which regulatory registry are SensID GmbH's devices listed?
SensID GmbH's devices are listed in the FDA's UDI (Unique Device Identification) registry, as indicated by the 'fda_udi' listing in the data. This registry tracks medical devices sold in the United States to support device traceability and post-market surveillance.
How are SensID GmbH's devices classified under regulatory frameworks?
SensID GmbH's devices are classified as Class II medical devices. This classification reflects their risk level and the regulatory controls required to ensure their safety and effectiveness, as stated directly in the provided device data.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 313586371
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SensID Idylla™ MSI FFPE Reference Set | 2x4 | FDA UDI | N/A | Active |
| Idylla™ MSI FFPE Reference Set | 2x5 | FDA UDI | Class II | Active |
| SensID Idylla™ MSI FFPE Reference Set | 2x3 | FDA UDI | Class II | Active |
| Idylla™ MSI FFPE Reference Set | SID-000114 | FDA UDI | Class II | Active |
| SensID Idylla™ MSI FFPE Reference Set | 2x2 | FDA UDI | Class II | Active |
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