Nichols Institute
Country not established
- Devices
- 14
What Nichols Institute makes
Nichols Institute produces in vitro diagnostic assays for hormone and protein analysis, including chemiluminescence immunoassays for thyroid hormones (TSH, free T3, DHEA-S), adrenal function (ACTH), and erythropoietin, as well as immunoradiometric assays (IRMA) like B2-microglobulin and thyroid peroxidase antibodies. Their portfolio also includes specialized controls for third-generation TSH testing and immunoassay kits for clinical laboratory use.
The company’s diagnostic assays are regulated under FDA’s 510(k) pathway, with devices classified as Class I or Class II. Products are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Catalogue
Search and filter all 14 devicesFrequently asked questions
How many devices does Nichols Institute have in the registry?
The registry currently lists 14 devices for Nichols Institute. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nichols Institute's devices?
Among its 14 most recently registered devices, Nichols Institute has devices listed in FDA 510(k) (14 devices).
What risk classes do Nichols Institute's devices fall under?
Among its 14 most recently registered devices, the classes recorded for Nichols Institute's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Nichols Institute in the registry?
The most recently registered devices listed for Nichols Institute include THYROGLOBULIN AUTOANTIBODY IMMUNOASSAY KIT, IMMUNORADIOMETERIC ASSAY (IRMA), APO A-1 CHEMILUMINESCENCE ASSAY and ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM.