Ibl-Hamburg GmbH
Country not established
- Devices
- 2
What Ibl-Hamburg GmbH makes
Ibl-Hamburg GmbH manufactures diagnostic tests for measuring acetylcholine receptor antibodies (ARA/RRA) and cortisol levels via enzyme-linked immunosorbent assay (ELISA) kits. These products are designed for laboratory use to aid in the detection and monitoring of autoimmune conditions and endocrine disorders.
The company’s diagnostic tests are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in the United States, where they are subject to compliance with FDA requirements for in vitro diagnostic devices.
Catalogue
Acetylcholine Receptor Ab (Arab)Rra Ref K051144
Regimes: 510(k) Registry: 510(k)Cortisol Elisa Ref K062626
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ibl-Hamburg GmbH have in the registry?
The registry currently lists 2 devices for Ibl-Hamburg GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ibl-Hamburg GmbH's devices?
Among its 2 most recently registered devices, Ibl-Hamburg GmbH has devices listed in FDA 510(k) (2 devices).
What risk classes do Ibl-Hamburg GmbH's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Ibl-Hamburg GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ibl-Hamburg GmbH in the registry?
The most recently registered devices listed for Ibl-Hamburg GmbH include ACETYLCHOLINE RECEPTOR AB (ARAB)RRA and CORTISOL ELISA.