Incstar Corp.
United StatesFDA applicant, unverified
- Devices
- 59
What Incstar Corp. makes
Incstar Corp. manufactures diagnostic in-vitro assays and allergen discs, including ELISA kits for detecting antibodies to cytomegalovirus, Epstein-Barr virus, and toxoplasmosis, as well as enzyme-bead-based immunoassays for beta-2 microglobulin. The company also produces allergen-specific discs for birch, dandelion, pigweed, and sweet vernal, alongside calibrators for IgE immunoassays and short ragweed test kits.
The portfolio includes devices classified as Class I, Class II, and Class III under FDA regulations, with some products authorised via 510(k) clearances and others through PMA submissions. These products are listed in the FDA’s regulatory databases and are manufactured in the United States.
Catalogue
Search and filter all 59 devicesShowing 1-50 of 59
Frequently asked questions
How many devices does Incstar Corp. have in the registry?
The registry currently lists 59 devices for Incstar Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Incstar Corp.'s devices?
Among its 50 most recently registered devices, Incstar Corp. has devices listed in FDA 510(k) (50 devices).
What risk classes do Incstar Corp.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Incstar Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Incstar Corp. in the registry?
The most recently registered devices listed for Incstar Corp. include INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530, INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KIT, INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGG ELISA KIT and INCSTAR'S BIRCH ALLERGEN DISC.