Curetis GmbH
GermanyFDA 510(k) applicant, unverified
- Devices
- 12
What Curetis GmbH makes
Curetis GmbH manufactures molecular diagnostic systems, including the Unyvero LRT BAL Application and the Curetis Unyvero LRT Application, designed for rapid detection of respiratory pathogens in clinical samples. These devices are intended for use in laboratory settings to identify infections such as tuberculosis and other lower respiratory tract pathogens.
The company’s portfolio is regulated as Class II medical devices in the United States, with products listed under the FDA’s 510(k) pathway. These devices are intended for commercial distribution within the US market.
Catalogue
Search and filter all 12 devicesCompany details
- DUNS number
- 312621863
- [email protected]
- Phone
- 301-869-9683
Frequently asked questions
How many devices does Curetis GmbH have in the registry?
The registry currently lists 12 devices for Curetis GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Curetis GmbH's devices?
Among its 12 most recently registered devices, Curetis GmbH has devices listed in FDA 510(k) (2 devices) and FDA GUDID (10 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Curetis GmbH's devices fall under?
Among its 12 most recently registered devices, the classes recorded for Curetis GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Curetis GmbH in the registry?
The most recently registered devices listed for Curetis GmbH include Acuitas QIAGEN® EZ1® Advanced XL System, Acuitas, Unyvero LRT BAL Cartridge Kit and Acuitas AMR Gene Panel PCR Plate Kit.