Genesis Diagnostics, Ltd.
United KingdomFDA applicant, unverified
- Devices
- 1
What Genesis Diagnostics, Ltd. makes
Genesis Diagnostics, Ltd. manufactures an enzyme-linked immunosorbent assay (ELISA) test for detecting gliadin antibodies, used in diagnosing celiac disease or gluten sensitivity.
The company’s portfolio is regulated under FDA’s Class II device classification, with the test listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Gliadin Antibodies Elisa Ref K973910
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Genesis Diagnostics, Ltd. have in the registry?
The registry currently lists 1 device for Genesis Diagnostics, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Genesis Diagnostics, Ltd.'s devices?
Among its 1 most recently registered device, Genesis Diagnostics, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Genesis Diagnostics, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Genesis Diagnostics, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Genesis Diagnostics, Ltd. in the registry?
The most recently registered devices listed for Genesis Diagnostics, Ltd. include GLIADIN ANTIBODIES ELISA.