Scimedx Corp.
United StatesFDA applicant, unverified
Scimedx Corp. is a medical device manufacturer, with 285 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) as of 14 Nov 2026.
- Devices
- 285
Registry facts
- Registries
- FDA GUDID 271
- FDA 510(k) 14
- Device classes
- FDA Class II 257
- FDA Class I 28
What Scimedx Corp. makes
Scimedx Corp. manufactures in vitro diagnostic (IVD) kits and fluorescent immunoassays for detecting various antibodies, including antinuclear antibodies (ANA), mitochondrial antibodies M2, smooth muscle antibodies, intrinsic factor/parietal cell antibodies, striated muscle antibodies, endomysium antibodies, Legionella pneumophila total antibodies, and multiple thyroid antibodies.
The company's devices are classified as Class I and Class II and are listed in the FDA 510(k) and FDA UDI registries.
Catalogue
Search and filter all 285 devicesShowing 1-50 of 285
Frequently asked questions
How many devices does Scimedx Corp. have in the registry?
The registry currently lists 285 devices for Scimedx Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Scimedx Corp.'s devices?
Among its 50 most recently registered devices, Scimedx Corp. has devices listed in FDA GUDID (50 devices).
What risk classes do Scimedx Corp.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Scimedx Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Scimedx Corp. in the registry?
The most recently registered devices listed for Scimedx Corp. include MeDiCa 8021-400-M, DNA(C.lucilae) 500 Test(L) D500L, Cytomegalovirus 10wl/10 pk I-CMV01X and R. STM Pack 4 WELL 3001.