Nuclear Medical Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 24
What Nuclear Medical Laboratories, Inc. makes
Nuclear Medical Laboratories, Inc. manufactures diagnostic radioimmunoassay (RIA) kits and automated gamma scintillation counters for measuring hormone levels, including thyroid-stimulating hormone (TSH), digoxin, cortisol, and chorionic gonadotropin. Their portfolio includes specialized assay systems like the COMPU-PET 300 for quantitative diagnostic testing and the NML 6000 CT for automated gamma counting. Additional products include lactose quantification assays and radiolabeled diagnostic reagents for clinical laboratory use.
The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) clearance database. These products are intended for in vitro diagnostic use and are listed under the U.S. jurisdiction. The manufacturer operates from the United States.
Catalogue
Search and filter all 24 devicesFrequently asked questions
How many devices does Nuclear Medical Laboratories, Inc. have in the registry?
The registry currently lists 24 devices for Nuclear Medical Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nuclear Medical Laboratories, Inc.'s devices?
Among its 24 most recently registered devices, Nuclear Medical Laboratories, Inc. has devices listed in FDA 510(k) (24 devices).
What risk classes do Nuclear Medical Laboratories, Inc.'s devices fall under?
Among its 24 most recently registered devices, the classes recorded for Nuclear Medical 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 Nuclear Medical Laboratories, Inc. in the registry?
The most recently registered devices listed for Nuclear Medical Laboratories, Inc. include NML TSH IRMA, CHORIC-SHURE, COMPU-PET 300 and NML 6000 CT.