Thyroid Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Thyroid Diagnostics, Inc. makes
Thyroid Diagnostics, Inc. manufactures diagnostic reagents, including the GLYCO-CHECK for thyroid function testing and the J & S IRON SATURATING REAGENT for iron saturation assays. These products support laboratory-based measurements of thyroid hormones and iron metabolism markers.
The company’s portfolio includes Class I and Class II devices, with some products listed via the FDA’s 510(k) pathway. These reagents are intended for in vitro diagnostic use and comply with applicable US regulatory requirements.
Catalogue
Glyco-Check Ref K852111
Regimes: 510(k) Registry: 510(k)J & S Iron Saturating Reagent Ref K811942
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Thyroid Diagnostics, Inc. have in the registry?
The registry currently lists 2 devices for Thyroid Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Thyroid Diagnostics, Inc.'s devices?
Among its 2 most recently registered devices, Thyroid Diagnostics, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Thyroid Diagnostics, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Thyroid Diagnostics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Thyroid Diagnostics, Inc. in the registry?
The most recently registered devices listed for Thyroid Diagnostics, Inc. include GLYCO-CHECK and J & S IRON SATURATING REAGENT.