Casco Standards
Country not established
- Devices
- 38
What Casco Standards makes
Casco Standards manufactures calibration verification test sets, linearity test sets, and control materials for clinical chemistry and molecular pathology assays. These include enzyme-based controls, calibration verification sets for ammonia, ethanol, triglycerides, iron, magnesium, HDL cholesterol, and uric acid, as well as molecular pathology controls for *Chlamydia trachomatis*. The company also produces assayed controls for cardiac markers and therapeutic drug monitoring (TDM).
The portfolio consists of Class I and Class II devices, regulated under the FDA’s 510(k) pathway. Products are listed in the U.S. regulatory system and comply with applicable standards for laboratory testing controls and calibration materials.
Catalogue
Search and filter all 38 devicesFrequently asked questions
How many devices does Casco Standards have in the registry?
The registry currently lists 38 devices for Casco Standards. Devices recorded under merged duplicate company entries are counted once.
Which registries list Casco Standards's devices?
Among its 38 most recently registered devices, Casco Standards has devices listed in FDA 510(k) (38 devices).
What risk classes do Casco Standards's devices fall under?
Among its 38 most recently registered devices, the classes recorded for Casco Standards's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Casco Standards in the registry?
The most recently registered devices listed for Casco Standards include DOCUMENT ENZYME, DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL, DOCUMENT ENZYME LINEARITY TEST SETS and DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET.