Iris Diagnostics, A Division of Iris International, Inc.
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- Devices
- 1
What Iris Diagnostics, A Division of Iris International, Inc. makes
Iris Diagnostics manufactures the iChemVELOCITY, an automated urine chemistry analyzer designed for laboratory testing of urine samples. This system performs biochemical assays to measure key analytes such as electrolytes, glucose, ketones, and proteins, supporting clinical diagnostics and patient monitoring.
The iChemVELOCITY is classified as a Class II medical device under FDA regulations and has been cleared via the 510(k) pathway. The company is headquartered in the United States.
Catalogue
iChemVELOCITY Automated Urine Chemistry System Ref K171083
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Iris Diagnostics, A Division of Iris International, Inc. have in the registry?
The registry currently lists 1 device for Iris Diagnostics, A Division of Iris International, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Iris Diagnostics, A Division of Iris International, Inc.'s devices?
Among its 1 most recently registered device, Iris Diagnostics, A Division of Iris International, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Iris Diagnostics, A Division of Iris International, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Iris Diagnostics, A Division of Iris International, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Iris Diagnostics, A Division of Iris International, Inc. in the registry?
The most recently registered devices listed for Iris Diagnostics, A Division of Iris International, Inc. include iChemVELOCITY Automated Urine Chemistry System.