Intl. Immunoassay Laboratories, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 27
What Intl. Immunoassay Laboratories, Inc. makes
The company produces diagnostic immunoassay kits and test procedures for quantifying cardiac markers, hormones, and tumor antigens, including troponin (MB fraction), carcinoembryonic antigen (CEA), and human chorionic gonadotropin (hCG). Products include enzyme immunoassay (EIA) kits, radioimmunoassay (RIA) kits, and modified test procedures for clinical laboratory use.
These devices are classified as Class I or Class II under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Search and filter all 27 devicesFrequently asked questions
How many devices does Intl. Immunoassay Laboratories, Inc. have in the registry?
The registry currently lists 27 devices for Intl. Immunoassay Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Intl. Immunoassay Laboratories, Inc.'s devices?
Among its 27 most recently registered devices, Intl. Immunoassay Laboratories, Inc. has devices listed in FDA 510(k) (27 devices).
What risk classes do Intl. Immunoassay Laboratories, Inc.'s devices fall under?
Among its 27 most recently registered devices, the classes recorded for Intl. Immunoassay 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 Intl. Immunoassay Laboratories, Inc. in the registry?
The most recently registered devices listed for Intl. Immunoassay Laboratories, Inc. include IMACK-MB TEST PROCEDURE (MODIFICATION), MYDAS(TM)-MB2/MYDAS(TM)-MB, EMBRIA-CK and IMMUNOCCULT-LXI.