Karo Bio Diagnostics AB
Country not established
- Devices
- 1
What Karo Bio Diagnostics AB makes
Karo Bio Diagnostics AB manufactures the PHADEBACT Monoclonal GC Test, a modification of a diagnostic assay designed for detecting *Neisseria gonorrhoeae* (GC) using monoclonal antibody technology. The test is intended for in vitro use in clinical laboratories to identify gonococcal infections from patient specimens.
The product falls under Class II regulatory classification and is listed in the FDA 510(k) database as a cleared diagnostic device. The company is based in the United States.
Catalogue
Phadebact Monoclonal Gc Test, Modification Ref K921075
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Karo Bio Diagnostics AB have in the registry?
The registry currently lists 1 device for Karo Bio Diagnostics AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Karo Bio Diagnostics AB's devices?
Among its 1 most recently registered device, Karo Bio Diagnostics AB has devices listed in FDA 510(k) (1 device).
What risk classes do Karo Bio Diagnostics AB's devices fall under?
Among its 1 most recently registered device, the classes recorded for Karo Bio Diagnostics AB's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Karo Bio Diagnostics AB in the registry?
The most recently registered devices listed for Karo Bio Diagnostics AB include PHADEBACT MONOCLONAL GC TEST, MODIFICATION.