Sorrento Biochemical, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Sorrento Biochemical, Inc. makes
Sorrento Biochemical, Inc. manufactures aqueous glucose control solutions designed for testing and calibration of blood glucose monitoring systems. These include low and high concentration controls for both standard and ultra-sensitive measurement ranges, labeled as PRESTIGE, ULTRA+, and DIASCAN series.
The company’s glucose control solutions are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in the United States, where they are registered with the FDA.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sorrento Biochemical, Inc. have in the registry?
The registry currently lists 3 devices for Sorrento Biochemical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sorrento Biochemical, Inc.'s devices?
Among its 3 most recently registered devices, Sorrento Biochemical, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Sorrento Biochemical, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Sorrento Biochemical, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Sorrento Biochemical, Inc. in the registry?
The most recently registered devices listed for Sorrento Biochemical, Inc. include PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH, ULTRA + AQUEOUS GLUCLOSE CONTROL LOW ULTRA + AQUEOUS GLUCOSE CONTROL HIGH and DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN AQUEOUS GLUCOSE CONTROL HIGH.