Radioimmunoassay, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
What Radioimmunoassay, Inc. makes
Radioimmunoassay, Inc. manufactures diagnostic radioimmunoassay (RIA) systems and reagents for measuring hormone levels in blood and serum. Products include kits and systems for thyroid stimulating hormone, digoxin, testosterone, cortisol, follicle stimulating hormone, luteinizing hormone, and triiodothyronine assays, as well as specific reagents like 125I-T4 and 125I-T3 uptake solutions.
These devices are classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) database. The company’s portfolio is listed in the US regulatory registry, reflecting compliance with applicable diagnostic device regulations.
Catalogue
Thyroid Stimulating Hormone Ref K792154
Regimes: 510(k) Registry: 510(k)Digoxin Radioimmunoassay System Ref K792153
Regimes: 510(k) Registry: 510(k)Testosterone Radioimmunoassy Kit Ref K802135
Regimes: 510(k) Registry: 510(k)Cortisol Radioimmunoassay System Ref K792036
Regimes: 510(k) Registry: 510(k)125 I-T4 Ria Reagent Ref K780672
Regimes: 510(k) Registry: 510(k)125 I-T3 Uptake Reagent Ref K780671
Regimes: 510(k) Registry: 510(k)Follicle Stimulating Hormone Ref K800107
Regimes: 510(k) Registry: 510(k)Luteinizing Hormone Radioimmunoassay Sys Ref K800106
Regimes: 510(k) Registry: 510(k)Triiodothyronine Ria System Ref K792539
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Radioimmunoassay, Inc. have in the registry?
The registry currently lists 9 devices for Radioimmunoassay, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Radioimmunoassay, Inc.'s devices?
Among its 9 most recently registered devices, Radioimmunoassay, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Radioimmunoassay, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Radioimmunoassay, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Radioimmunoassay, Inc. in the registry?
The most recently registered devices listed for Radioimmunoassay, Inc. include THYROID STIMULATING HORMONE, DIGOXIN RADIOIMMUNOASSAY SYSTEM, TESTOSTERONE RADIOIMMUNOASSY KIT and CORTISOL RADIOIMMUNOASSAY SYSTEM.