Bio-Ria
Country not established
- Devices
- 2
What Bio-Ria makes
Bio-Ria manufactures radioimmunoassay kits for laboratory testing, including the 125I-IgE Radioimmunoassay Kit and the 125I-Ferritin Radioimmunoassay Kit. These products are designed for quantifying specific antigens in serum or plasma samples using radioactive iodine (125I) labeling.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. The portfolio is listed in the FDA’s 510(k) database, reflecting their regulatory pathway in the United States.
Catalogue
125I-Ige Radioimmunoassay Kit Ref K801019
Regimes: 510(k) Registry: 510(k)125I Ferritin Radioimmunoassay Kit Ref K812901
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bio-Ria have in the registry?
The registry currently lists 2 devices for Bio-Ria. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bio-Ria's devices?
Among its 2 most recently registered devices, Bio-Ria has devices listed in FDA 510(k) (2 devices).
What risk classes do Bio-Ria's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Bio-Ria's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bio-Ria in the registry?
The most recently registered devices listed for Bio-Ria include 125I-IGE RADIOIMMUNOASSAY KIT and 125I FERRITIN RADIOIMMUNOASSAY KIT.