Abbott Laboratories Diagnostics Division
Active in EUDAMEDUnited Statesfrom EUDAMED address EUDAMED SRN US-MF-000034407
- Devices
- 4
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
Catalogue
Alkaline Phosphatase Ref K240468
Regimes: 510(k) Registry: 510(k)Alinity i STAT High Sensitivity Troponin-I Ref K230994
Regimes: 510(k) Registry: 510(k)ARCHITECT STAT High Sensitivity Troponin-I Ref K191595
Regimes: 510(k) Registry: 510(k)Alinity i STAT High Sensitivity Troponin-I Ref K202525
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- US-MF-000034407
- EUDAMED status
- Active
- EUDAMED registered name
- Abbott Laboratories Diagnostics Division
- [email protected]
- PRRC contact
- Jacek Gorzowski
Frequently asked questions
How many devices does Abbott Laboratories Diagnostics Division have in the registry?
The registry currently lists 4 devices for Abbott Laboratories Diagnostics Division. Devices recorded under merged duplicate company entries are counted once.
Which registries list Abbott Laboratories Diagnostics Division's devices?
Among its 4 most recently registered devices, Abbott Laboratories Diagnostics Division has devices listed in FDA 510(k) (4 devices).
What risk classes do Abbott Laboratories Diagnostics Division's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Abbott Laboratories Diagnostics Division's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Abbott Laboratories Diagnostics Division in the registry?
The most recently registered devices listed for Abbott Laboratories Diagnostics Division include Alkaline Phosphatase, Alinity i STAT High Sensitivity Troponin-I and ARCHITECT STAT High Sensitivity Troponin-I.