Ibl GmbH
Country not established
- Devices
- 6
What Ibl GmbH makes
Ibl GmbH manufactures reagent-based in vitro diagnostic (IVD) devices for hormone detection, including chemiluminescent immunoassays (CIA/EIA) for C1q, C3d, testosterone, progesterone, and estradiol in serum and saliva. The company also produces infusion pumps for administering adrenaline, noradrenaline, and dopamine in critical care settings, such as the TRICAT RIA and KATCOMBI RIA systems.
The portfolio includes Class I and Class II devices, with some products authorised via the FDA’s 510(k) pathway. These products are listed in the FDA’s regulatory database, and the company is based in the United States.
Catalogue
Tricat Ria (Adrenalin/Noradrenalin/Dopamine); Katcombi Ria (Adrenalin/Noradrenalin); Noradrenalin Ria Ref K051969
Regimes: 510(k) Registry: 510(k)Ibl C1Q-Cic Cia Test Ref K032254
Regimes: 510(k) Registry: 510(k)Ibl C3D-Cic Eia Test Ref K032796
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ibl GmbH have in the registry?
The registry currently lists 6 devices for Ibl GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ibl GmbH's devices?
Among its 6 most recently registered devices, Ibl GmbH has devices listed in FDA 510(k) (6 devices).
What risk classes do Ibl GmbH's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Ibl GmbH's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ibl GmbH in the registry?
The most recently registered devices listed for Ibl GmbH include TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA, IBL C1Q-CIC CIA TEST, IBL C3D-CIC EIA TEST and LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA.