Inverness Medical Innovations, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Inverness Medical Innovations, Inc. makes
Inverness Medical Innovations produces diagnostic assays and test systems for cardiovascular and metabolic monitoring, including the Albumin Cobalt Binding Test (ACB Test) for ischemia assessment and verification sets. The company also manufactures blood glucose monitoring systems, such as the One Touch FastTake Compact and Ultra systems, as well as the Induo blood glucose meter.
These devices are regulated under FDA 510(k) clearance, with classifications spanning Class I and Class II. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Ischemia Albumin Cobalt Binding Test (Acb Test) Ref K053196
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Smartcheck Inr System Ref K071265
Regimes: 510(k) Registry: 510(k)One Touch Fasttake Compact Blood Glucose Monitoring System, One Touch Ultra Blood Glucose Monitoring System Ref K011479
Regimes: 510(k) Registry: 510(k)Induo Blood Glucose Meter Ref K011616
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Inverness Medical Innovations, Inc. have in the registry?
The registry currently lists 6 devices for Inverness Medical Innovations, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Inverness Medical Innovations, Inc.'s devices?
Among its 6 most recently registered devices, Inverness Medical Innovations, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Inverness Medical Innovations, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Inverness Medical Innovations, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Inverness Medical Innovations, Inc. in the registry?
The most recently registered devices listed for Inverness Medical Innovations, Inc. include ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY, ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST), ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET and SMARTCHECK INR SYSTEM.