Bioclinical Group
Country not established
- Devices
- 9
What Bioclinical Group makes
The company produces diagnostic radioimmunoassay kits for measuring hormone levels in blood or serum, including cortisol, thyroid hormones (T3, T4), luteinizing hormone (LH), follicle-stimulating hormone (FSH), and human chorionic gonadotropin (hCG). These kits are designed for laboratory use to quantify specific biomarkers in clinical settings.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with several products authorised via the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) database, reflecting their regulatory status in the United States.
Catalogue
Cortisol Radioimmunoassay Kit Ref K832638
Regimes: 510(k) Registry: 510(k)Total Radioimmunoassay Kit Ref K821101
Regimes: 510(k) Registry: 510(k)Free T3 Radioimmunoassay Kit Ref K862968
Regimes: 510(k) Registry: 510(k)Lh/Fsh Radioimmunoassay Kit Ref K853837
Regimes: 510(k) Registry: 510(k)Bio Mag Free T4 Radioimmunoassay Kit Ref K823005
Regimes: 510(k) Registry: 510(k)B-Hcg Radioimmunoassay Kit Ref K822515
Regimes: 510(k) Registry: 510(k)Bio Mag Total T4 Radioimmunoassay Kit Ref K823004
Regimes: 510(k) Registry: 510(k)Free T4 Radioimmunoassay Kit Ref K821241
Regimes: 510(k) Registry: 510(k)Radioimmunoassay, Human Chorrionic Ref K822840
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bioclinical Group have in the registry?
The registry currently lists 9 devices for Bioclinical Group. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bioclinical Group's devices?
Among its 9 most recently registered devices, Bioclinical Group has devices listed in FDA 510(k) (9 devices).
What risk classes do Bioclinical Group's devices fall under?
Among its 9 most recently registered devices, the classes recorded for Bioclinical Group's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bioclinical Group in the registry?
The most recently registered devices listed for Bioclinical Group include CORTISOL RADIOIMMUNOASSAY KIT, TOTAL RADIOIMMUNOASSAY KIT, FREE T3 RADIOIMMUNOASSAY KIT and LH/FSH RADIOIMMUNOASSAY KIT.