New England Nuclear
Country not established
- Devices
- 18
What New England Nuclear makes
The company produces radioimmunoassay (RIA) kits and related assay systems for quantifying biological substances in clinical samples, including cortisol in plasma, prostatic acid, vitamin B12, gentamicin, prolactin, luteinizing hormone, ferritin, and tobramycin. These kits rely on radioactive iodine (125I) labeling for detection and measurement in diagnostic testing.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded via the 510(k) pathway. These products are intended for in vitro diagnostic use and are listed in the FDA’s 510(k) registry. The manufacturer operates from the United States.
Catalogue
Search and filter all 18 devicesFrequently asked questions
How many devices does New England Nuclear have in the registry?
The registry currently lists 18 devices for New England Nuclear. Devices recorded under merged duplicate company entries are counted once.
Which registries list New England Nuclear's devices?
Among its 18 most recently registered devices, New England Nuclear has devices listed in FDA 510(k) (18 devices).
What risk classes do New England Nuclear's devices fall under?
Among its 18 most recently registered devices, the classes recorded for New England Nuclear's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from New England Nuclear in the registry?
The most recently registered devices listed for New England Nuclear include RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA), RIA KIT, QUANTITATION OF PROSTATIC ACID, RIANEN CYCLIC-AMP RADIOIMMUNOASSAY and RIANEN, VITAMIN B12 ASSAY SYSTEM.