Direct Solutions
Country not established
- Devices
- 5
What Direct Solutions makes
Direct Solutions manufactures point-of-care diagnostic devices, including the EUROTROL Gas ISE Control for electrolyte measurement and the HEMOCUE series for blood glucose (Glucotrol, Glucolin) and hemoglobin (Hemotrol, Hemolin) testing. These products are designed for rapid, in-clinic analysis of blood chemistry parameters.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with several authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) database, reflecting their regulatory clearance for commercial distribution in the US.
Catalogue
Eurotrol Gas - Ise Control Ref K955340
Regimes: 510(k) Registry: 510(k)Hemocue Glucotrol Ref K964053
Regimes: 510(k) Registry: 510(k)Hemocue Hemotrol Ref K964052
Regimes: 510(k) Registry: 510(k)Hemocue Hemolin Ref K963908
Regimes: 510(k) Registry: 510(k)Hemocue Glucolin Ref K963909
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Direct Solutions have in the registry?
The registry currently lists 5 devices for Direct Solutions. Devices recorded under merged duplicate company entries are counted once.
Which registries list Direct Solutions's devices?
Among its 5 most recently registered devices, Direct Solutions has devices listed in FDA 510(k) (5 devices).
What risk classes do Direct Solutions's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Direct Solutions's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Direct Solutions in the registry?
The most recently registered devices listed for Direct Solutions include EUROTROL GAS - ISE CONTROL, HEMOCUE GLUCOTROL, HEMOCUE HEMOTROL and HEMOCUE HEMOLIN.