Iris International, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
What Iris International, Inc. makes
Iris International, Inc. makes urine chemistry and body fluid analyzers, including the IQ 20 Series Analyzer, IQ 200 Series System, Nad IQ Lamina Cradle, IQ 200 Urine Analyzer Body Fluids Module, and Ichem 100 Urine Chemistry Analyzer.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Regimes: 510(k) Registry: 510(k)
Iq 200 Urine Analyzer Body Fluids Module Ref K050235
Regimes: 510(k) Registry: 510(k)Ichem 100 Urine Chemistry Analyzer Ref K060280
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 098240690
Frequently asked questions
How many devices does IRIS INTERNATIONAL, INC. have in the registry?
The registry currently lists 10 devices for IRIS INTERNATIONAL, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list IRIS INTERNATIONAL, INC.'s devices?
Among its 10 most recently registered devices, IRIS INTERNATIONAL, INC. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (7 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do IRIS INTERNATIONAL, INC.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for IRIS INTERNATIONAL, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from IRIS INTERNATIONAL, INC. in the registry?
The most recently registered devices listed for IRIS INTERNATIONAL, INC. include iQ®200 iQ® Lamina™ Cradle, StatSpin X00-003808-001, vChem® vChem®10 SG Urine Chemistry Strips and iChem®10SG Urine Chemistry Strips.