Kallestad Diag, A Div. of Erbamont, Inc.
United StatesFDA applicant, unverified
- Devices
- 58
What Kallestad Diag, A Div. of Erbamont, Inc. makes
The company produces in vitro diagnostic (IVD) test kits and reagents for laboratory use, including serological assays for toxoplasmosis (IgM), rheumatoid factor, thyroid hormones (thyroxine), and protein markers like alpha-2 macroglobulin, prealbumin, and haptoglobin. It also supplies calibrators and control materials for quality assurance in automated immunoassay systems such as the QM2 and QM300 platforms.
These products are regulated under FDA’s Class I and Class II IVD categories, with most cleared via the 510(k) pathway. The company’s devices are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Search and filter all 58 devicesShowing 1-50 of 58
Frequently asked questions
How many devices does Kallestad Diag, A Div. of Erbamont, Inc. have in the registry?
The registry currently lists 58 devices for Kallestad Diag, A Div. of Erbamont, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kallestad Diag, A Div. of Erbamont, Inc.'s devices?
Among its 50 most recently registered devices, Kallestad Diag, A Div. of Erbamont, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Kallestad Diag, A Div. of Erbamont, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Kallestad Diag, A Div. of Erbamont, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Kallestad Diag, A Div. of Erbamont, Inc. in the registry?
The most recently registered devices listed for Kallestad Diag, A Div. of Erbamont, Inc. include PLATELIA TOXO IGM KIT, QM300 CONTROL E, MODIFIED QM300 RHEUMATOID FACTOR TEST and KALLESTAD QM300 CALIBRATOR C PACK.