Kallestad Laboratories, Inc.

Kallestad Laboratories, Inc. manufactures diagnostic reagent kits and antisera for radioimmunoassay (RIA) testing, including quantitation kits for gentamicin, cortisol, thyroid hormones (T3, T4), immunoglobulin levels (IgA, IgE), and phenobarbital. The company also produces antisera for detecting tobramycin and free kappa chains in human samples, as well as reagent kits for neonatal thyroid function testing. Their product line includes both standalone assay components and integrated systems like the MARK 500.

The company’s diagnostic reagents are classified under FDA’s Class I and Class II categories, with regulatory submissions recorded via the 510(k) pathway. These products are intended for in vitro use and are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.