Joldon Diagnostics
CanadaFDA applicant, unverified
- Devices
- 2
What Joldon Diagnostics makes
Joldon Diagnostics manufactures enzyme immunoassay (EIA) test kits for detecting thyroid-related auto-antibodies, including thyroglobulin auto-antibody and thyroid microsomal antigen auto-antibody.
These diagnostic devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Thyroglobulin Auto-Antibody Eia Test Kit Ref K925194
Regimes: 510(k) Registry: 510(k)Thyroid Microsomal Antigen Auto-Antibody Enzyme Ref K930274
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Joldon Diagnostics have in the registry?
The registry currently lists 2 devices for Joldon Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Joldon Diagnostics's devices?
Among its 2 most recently registered devices, Joldon Diagnostics has devices listed in FDA 510(k) (2 devices).
What risk classes do Joldon Diagnostics's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Joldon Diagnostics's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Joldon Diagnostics in the registry?
The most recently registered devices listed for Joldon Diagnostics include THYROGLOBULIN AUTO-ANTIBODY EIA TEST KIT and THYROID MICROSOMAL ANTIGEN AUTO-ANTIBODY ENZYME.