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 devicesRrt Total Ige Test Kit Ref K874541
Regimes: 510(k) Registry: 510(k)Epo-Trac By Radioimmunoassay (Ria) Ref K893393
Regimes: 510(k) Registry: 510(k)Pth-Mm Ii 125I Radioimmunoassay (Ria) Ref K901711
Regimes: 510(k) Registry: 510(k)Incstar Cytomegalovirus Igg Fast Elisa Assay Ref K955360
Regimes: 510(k) Registry: 510(k)Bahia Allergen Disc Ref K873648
Regimes: 510(k) Registry: 510(k)Incstar Rubella Igg Elisa Assay Ref K960367
Regimes: 510(k) Registry: 510(k)Bermuda Grass Allergen Disc Ref K873770
Regimes: 510(k) Registry: 510(k)Goldenrod Allergen Disc Ref K875163
Regimes: 510(k) Registry: 510(k)Gamma Dab (125I) Afp Ria Kit Ref P790032
Regimes: PMA, withdrawn Registry: PMA
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