Clever Culture Systems AG
SwitzerlandFDA applicant, unverified FDA
- Devices
- 5
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Clever Culture Systems AG makes
Clever Culture Systems AG produces automated microbial culture plate imaging and analysis systems for in vitro diagnostic (IVD) use, including standalone and modular solutions for urine sample testing. These systems digitize and analyze microbial growth patterns on culture plates, supporting automated detection and identification of pathogens. Examples include the APAS Independence, standalone and urine-specific modules, and the APAS Compact with urine analysis capabilities.
The company’s devices are classified as Class II under FDA regulations and are listed via 510(k) and UDI pathways. These systems are intended for clinical microbiology laboratories in the United States, where regulatory compliance is required for diagnostic software and imaging tools.
Catalogue
- Registry: GUDID
- Registry: GUDID
APAS Independence with Urine Analysis Module Ref K183648
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
APAS Compact with Urine Analysis Module Ref DEN150059
Regimes: De Novo Registry: De Novo
Company details
- DUNS number
- 487097888
FDA establishments
- Clever Culture Systems Limited Adelaide South Australia · AU FEI 3023339158
Frequently asked questions
How many devices does Clever Culture Systems AG have in the registry?
The registry currently lists 5 devices for Clever Culture Systems AG. Devices recorded under merged duplicate company entries are counted once.
Which registries list Clever Culture Systems AG's devices?
Among its 5 most recently registered devices, Clever Culture Systems AG has devices listed in FDA 510(k) (3 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Clever Culture Systems AG's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Clever Culture Systems AG's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Clever Culture Systems AG in the registry?
The most recently registered devices listed for Clever Culture Systems AG include APAS Independence, Urine 1uL TS-SBA/MacCV TFS 5.1, APAS Independence with Urine Analysis Module and APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module.
Which FDA establishments are linked to Clever Culture Systems AG?
1 FDA establishment is linked to Clever Culture Systems AG in the registry; they are listed on the company page.