Inverness Medical-Biostar, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
Catalogue
Biostar Oia Shigatox Ref K061889
Regimes: 510(k) Registry: 510(k)
FDA recalls
2008
- 2 Jul 2008 Z-0212-2009 Unclassified (pre-2012) Terminated Diagnostic kits for flu were distributed with incorrect components.
Frequently asked questions
How many devices does Inverness Medical-Biostar, Inc. have in the registry?
The registry currently lists 1 device for Inverness Medical-Biostar, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Inverness Medical-Biostar, Inc.'s devices?
Among its 1 most recently registered device, Inverness Medical-Biostar, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Inverness Medical-Biostar, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Inverness Medical-Biostar, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Inverness Medical-Biostar, Inc.?
FDA recall records list 1 recall initiated by Inverness Medical-Biostar, Inc., the most recent initiated on 2 Jul 2008. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Inverness Medical-Biostar, Inc. in the registry?
The most recently registered devices listed for Inverness Medical-Biostar, Inc. include BIOSTAR OIA SHIGATOX.