Advanced Magnetics, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Advanced Magnetics, Inc. makes
Advanced Magnetics, Inc. manufactures diagnostic radioimmunoassay kits for measuring thyroid hormones, including free T3, free T4, and modified free T4 levels. These kits are designed for laboratory use to quantify hormone concentrations in patient samples.
The company’s products fall under FDA Class II devices and are authorised via the 510(k) pathway. These assays are listed in the FDA’s 510(k) database, reflecting their regulatory clearance for commercial distribution in the US.
Catalogue
Free T3 Radioimmunoassay Kit Ref K894200
Regimes: 510(k) Registry: 510(k)Free T4 Immunoassay Kit Ref K900060
Regimes: 510(k) Registry: 510(k)Serozyme Free T3 Immunoassay Ref K902748
Regimes: 510(k) Registry: 510(k)Modified Free T4 Radioimmunoassay Kit Ref K884753
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Advanced Magnetics, Inc. have in the registry?
The registry currently lists 4 devices for Advanced Magnetics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Advanced Magnetics, Inc.'s devices?
Among its 4 most recently registered devices, Advanced Magnetics, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Advanced Magnetics, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Advanced Magnetics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Advanced Magnetics, Inc. in the registry?
The most recently registered devices listed for Advanced Magnetics, Inc. include FREE T3 RADIOIMMUNOASSAY KIT, FREE T4 IMMUNOASSAY KIT, SEROZYME FREE T3 IMMUNOASSAY and MODIFIED FREE T4 RADIOIMMUNOASSAY KIT.