Kallestad Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 92
What Kallestad Laboratories, Inc. makes
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.
Catalogue
Search and filter all 92 devicesShowing 1-50 of 92
Frequently asked questions
How many devices does Kallestad Laboratories, Inc. have in the registry?
The registry currently lists 92 devices for Kallestad Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kallestad Laboratories, Inc.'s devices?
Among its 50 most recently registered devices, Kallestad Laboratories, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Kallestad Laboratories, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Kallestad Laboratories, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Kallestad Laboratories, Inc. in the registry?
The most recently registered devices listed for Kallestad Laboratories, Inc. include QUANTITOPE 125-I GENTAMICIN RIA KIT, KALLESTAD ANTISERA TO TOBRAMYCIN, RIA KIT, QUANTITOPE CORTISOL and MARK 500 SYSTEM.