Immunomedics, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Immunomedics, Inc. makes
Immunomedics, Inc. manufactures in vitro diagnostic (IVD) immunoassay systems for detecting antibodies and antigens in serum and other biological samples. Their products include ELISA test systems for measuring human anti-mouse antibodies (HAMA), IgG, and double-stranded DNA (dsDNA), as well as immunoassay strips for specific antibody detection.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) clearance process. The company’s portfolio is listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Immunomedics Serum Elisa Test System Ref K861362
Regimes: 510(k) Registry: 510(k)Immustrip Hama Igg Ref K972873
Regimes: 510(k) Registry: 510(k)Immustrip(Tm) Sm Elisa Test System Ref K873741
Regimes: 510(k) Registry: 510(k)Immustrip(Tm) Dsdna Elisa Test System Ref K870903
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Immunomedics, Inc. have in the registry?
The registry currently lists 4 devices for Immunomedics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Immunomedics, Inc.'s devices?
Among its 4 most recently registered devices, Immunomedics, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Immunomedics, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Immunomedics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Immunomedics, Inc. in the registry?
The most recently registered devices listed for Immunomedics, Inc. include IMMUNOMEDICS SERUM ELISA TEST SYSTEM, IMMUSTRIP HAMA IGG, IMMUSTRIP(TM) SM ELISA TEST SYSTEM and IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM.