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 devicesDeviceDevice · Authorizations Verified Status Regime Registry Class
Platelia Rubella Igg Kit Ref K894946
Regimes: 510(k) Registry: 510(k)QM300 Albumin Antibody Pack Ref K882082
Regimes: 510(k) Registry: 510(k)QM300 Igg Antibody Pack Ref K882083
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Kallestad QM300 C-Reactive Protein Antibody Pack Ref K880728
Regimes: 510(k) Registry: 510(k)QM300 C4 Antibody Pack Ref K872599
Regimes: 510(k) Registry: 510(k)QM300 Control G Pack Ref K910887
Regimes: 510(k) Registry: 510(k)Modified QM300 Albumin Antibody Pack Ref K896059
Regimes: 510(k) Registry: 510(k)
Showing 51-58 of 58