Immunoprobe, Inc.
United StatesFDA applicant, unverified
- Devices
- 14
What Immunoprobe, Inc. makes
Immunoprobe, Inc. manufactures enzyme immunoassay (EIA) and enzyme-linked immunosorbent assay (ELISA) test systems for detecting specific antibodies and antigens in clinical samples. These include kits for cardiolipin (IgM, IgG, IgA, and combined), microsomal antigens, myeloperoxidase (MPO), proteinase-3 (PR-3), thyroglobulin, and Epstein-Barr nuclear antigen (EBNA-IgG). The products are designed for use in diagnostic laboratories to aid in the identification of autoimmune and infectious disease markers.
The company’s test systems are classified under FDA’s Class I and Class II regulatory categories, with some requiring 510(k) clearance. These devices are listed in the FDA’s 510(k) database, reflecting their authorised status for clinical use in the United States. Immunoprobe, Inc. is headquartered in the US.
Catalogue
Search and filter all 14 devicesFrequently asked questions
How many devices does Immunoprobe, Inc. have in the registry?
The registry currently lists 14 devices for Immunoprobe, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Immunoprobe, Inc.'s devices?
Among its 14 most recently registered devices, Immunoprobe, Inc. has devices listed in FDA 510(k) (14 devices).
What risk classes do Immunoprobe, Inc.'s devices fall under?
Among its 14 most recently registered devices, the classes recorded for Immunoprobe, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Immunoprobe, Inc. in the registry?
The most recently registered devices listed for Immunoprobe, Inc. include CARDIOLIPIN IGM EIA TEST SYSTEM, MICROSOMAL EIA TEST KIT, CARDIOLIPIN IGG, M, A EIA TEST KIT and MPO ELISA TEST SYSTEM.