Biomira, Inc.
Country not established
- Devices
- 2
What Biomira, Inc. makes
Biomira, Inc. manufactures the TRUQUANT BR RIA, a radioimmunoassay (RIA) test designed for quantifying beta-2 microglobulin in blood samples, primarily used in monitoring kidney function and disease progression.
This product is classified as a Class III medical device under FDA regulations and is authorised through a Premarket Approval Application (PMA). The company is based in the United States.
Catalogue
Truquant Br Ria Ref K965141
Regimes: 510(k) Registry: 510(k)Truquant(R) Br(Tm) Ria Ref P950011
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Biomira, Inc. have in the registry?
The registry currently lists 2 devices for Biomira, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biomira, Inc.'s devices?
Among its 2 most recently registered devices, Biomira, Inc. has devices listed in FDA 510(k) (1 device) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Biomira, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Biomira, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Biomira, Inc. in the registry?
The most recently registered devices listed for Biomira, Inc. include TRUQUANT BR RIA and TRUQUANT(R) BR(TM) RIA.