Cala Diagnostics
Country not established
- Devices
- 12
What Cala Diagnostics makes
Cala Diagnostics manufactures laboratory controls for cardiac biomarkers, including CKMB mass measurement and isoenzyme controls, as well as controls for serum and whole blood alcohol levels. Additional products cover cyclosporin A monitoring, fibrinogen/FDP assays, and lactate dehydrogenase (LD) isoenzyme verification. These controls are designed to validate analytical performance in clinical chemistry and immunology testing.
The company’s portfolio includes devices classified as Class I (general controls) and Class II (special controls) under FDA regulations, with submissions recorded in the FDA 510(k) database. Products are intended for use in US clinical laboratories and comply with relevant US regulatory requirements.
Catalogue
Search and filter all 12 devicesFrequently asked questions
How many devices does Cala Diagnostics have in the registry?
The registry currently lists 12 devices for Cala Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cala Diagnostics's devices?
Among its 12 most recently registered devices, Cala Diagnostics has devices listed in FDA 510(k) (12 devices).
What risk classes do Cala Diagnostics's devices fall under?
Among its 12 most recently registered devices, the classes recorded for Cala Diagnostics's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cala Diagnostics in the registry?
The most recently registered devices listed for Cala Diagnostics include CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL, CKMB ISOENZYME CONTROL-LEVEL 1, 2.3, SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 and LD-1 CONTROL-LEVEL 1 & 2.