Ismunit Istituto Immunologico Intaliano
ItalyFDA applicant, unverified
- Devices
- 2
What Ismunit Istituto Immunologico Intaliano makes
The company produces in vitro diagnostic tests for detecting specific antibodies, including the Chromotitre EIA Toxoplasma IgM for toxoplasmosis screening and the Chromotitre EIA Rubella IgG for rubella antibody measurement.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Chromotitre E.I.A. Toxoplasma Igm Ref K872070
Regimes: 510(k) Registry: 510(k)Chromotitre E.I.A. Rubella Igg Ref K872071
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ismunit Istituto Immunologico Intaliano have in the registry?
The registry currently lists 2 devices for Ismunit Istituto Immunologico Intaliano. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ismunit Istituto Immunologico Intaliano's devices?
Among its 2 most recently registered devices, Ismunit Istituto Immunologico Intaliano has devices listed in FDA 510(k) (2 devices).
What risk classes do Ismunit Istituto Immunologico Intaliano's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Ismunit Istituto Immunologico Intaliano's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ismunit Istituto Immunologico Intaliano in the registry?
The most recently registered devices listed for Ismunit Istituto Immunologico Intaliano include CHROMOTITRE E.I.A. TOXOPLASMA IGM and CHROMOTITRE E.I.A. RUBELLA IGG.