General Biometrics, Inc.
United StatesFDA applicant, unverified
- Devices
- 23
What General Biometrics, Inc. makes
General Biometrics, Inc. manufactures rapid diagnostic tests for infectious diseases and autoimmune conditions, including rubella, Lyme disease, thyroid autoimmunity, and Sjogren’s syndrome. Their products detect specific antibodies and antigens using lateral-flow or immunoassay formats, designed for point-of-care or laboratory use.
The company’s portfolio consists of Class II medical devices, regulated under the FDA’s 510(k) clearance process. These tests are listed in the FDA’s 510(k) database and are intended for use in the United States.
Catalogue
Search and filter all 23 devicesFrequently asked questions
How many devices does General Biometrics, Inc. have in the registry?
The registry currently lists 23 devices for General Biometrics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list General Biometrics, Inc.'s devices?
Among its 23 most recently registered devices, General Biometrics, Inc. has devices listed in FDA 510(k) (23 devices).
What risk classes do General Biometrics, Inc.'s devices fall under?
Among its 23 most recently registered devices, the classes recorded for General Biometrics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from General Biometrics, Inc. in the registry?
The most recently registered devices listed for General Biometrics, Inc. include IMMUNODOT TORCH TEST RUBELLA, IMMUNODOT THYROID AUTOIMMUNITY PANEL, IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST and IMMUNODOT AUTOIMMUNE SCREENING PANEL 1.