ORGENTEC Diagnostika GmbH
Country not established
Part of Orgentec Diagnostika GmbH
- Devices
- 22
What ORGENTEC Diagnostika GmbH makes
ORGENTEC Diagnostika GmbH manufactures in vitro diagnostic (IVD) kits for detecting mutated citrullinated vimentin (MCV) antibodies using enzyme immunoassay (EIA) technology. These products are designed for laboratory testing to support the identification of specific biomarkers associated with autoimmune conditions. The primary offering, ANTI-MCV, is a reagent-based kit used in clinical diagnostics to measure antibody levels in patient samples.
The company’s MCV antibody detection kits fall under Class II regulatory classification in the US, requiring performance validation and submission to regulatory authorities. These devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with US medical device regulations. The manufacturer operates from its base in Germany, adhering to European and international regulatory standards for IVD products.
Catalogue
Search and filter all 22 devicesCompany details
- DUNS number
- 328133103
- [email protected]
- Phone
- +49061319258
Frequently asked questions
How many devices does ORGENTEC Diagnostika GmbH have in the registry?
The registry currently lists 22 devices for ORGENTEC Diagnostika GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list ORGENTEC Diagnostika GmbH's devices?
Among its 22 most recently registered devices, ORGENTEC Diagnostika GmbH has devices listed in EUDAMED (2 devices) and FDA GUDID (22 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do ORGENTEC Diagnostika GmbH's devices fall under?
Among its 22 most recently registered devices, the classes recorded for ORGENTEC Diagnostika GmbH's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from ORGENTEC Diagnostika GmbH in the registry?
The most recently registered devices listed for ORGENTEC Diagnostika GmbH include ANTI-TG ORG502, RHEUMATOID FACTOR IgG ORG522G, ANTI-TPO ORG503 and ANTI-PR3 (cANCA) ORG518.