Icn Immunobiologicals
Country not established
- Devices
- 2
What Icn Immunobiologicals makes
Icn Immunobiologicals manufactures diagnostic test kits for infectious disease detection, including the IMMU-MARK™ Chlamydia IgG/IgA immunoassay kit and ACCRAASSAY RID kits for rapid immunodiagnostic testing.
These products are regulated under FDA 510(k) clearance, with devices classified as Class I and Class II. The company’s diagnostic tests are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Immu-Mark(Tm) Chlamydia Igg/Iga Kit Ref K882674
Regimes: 510(k) Registry: 510(k)Accraassay Rid Kits Ref K882369
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Icn Immunobiologicals have in the registry?
The registry currently lists 2 devices for Icn Immunobiologicals. Devices recorded under merged duplicate company entries are counted once.
Which registries list Icn Immunobiologicals's devices?
Among its 2 most recently registered devices, Icn Immunobiologicals has devices listed in FDA 510(k) (2 devices).
What risk classes do Icn Immunobiologicals's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Icn Immunobiologicals's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Icn Immunobiologicals in the registry?
The most recently registered devices listed for Icn Immunobiologicals include IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT and ACCRAASSAY RID KITS.