Radioassay Systems Laboratories, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 15
What Radioassay Systems Laboratories, Inc. makes
Radioassay Systems Laboratories, Inc. manufactures diagnostic radioimmunoassay (RIA) kits for measuring hormone levels in blood and serum, including aldosterone, estrogens, progesterone, estradiol, dehydroepiandrosterone sulfate, androstenedione, cortisol, and pregnancy detection markers. The kits also support quantitation procedures for hormones like 11-desoxycortisol and hydroxprogesterone.
The company’s products are classified under FDA device classes I and II and are listed via 510(k) premarket notifications. These assays are intended for in vitro diagnostic use and are regulated under U.S. FDA authorities.
Catalogue
Search and filter all 15 devicesFrequently asked questions
How many devices does Radioassay Systems Laboratories, Inc. have in the registry?
The registry currently lists 15 devices for Radioassay Systems Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Radioassay Systems Laboratories, Inc.'s devices?
Among its 15 most recently registered devices, Radioassay Systems Laboratories, Inc. has devices listed in FDA 510(k) (15 devices).
What risk classes do Radioassay Systems Laboratories, Inc.'s devices fall under?
Among its 15 most recently registered devices, the classes recorded for Radioassay Systems 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 Radioassay Systems Laboratories, Inc. in the registry?
The most recently registered devices listed for Radioassay Systems Laboratories, Inc. include RSL (125I) ALDOSTERONE KIT, TOTAL ESTROGENS KIT BY RIA, RSL (125 L) PROGESTERONE KIT and ESTRADIOL KIT BY RIA.