Allergenetics
Country not established
- Devices
- 8
What Allergenetics makes
Allergenetics produces in-vitro diagnostic tests for measuring immunoglobulin E (IgE) levels, including allergen-specific IgE assays and total IgE quantification. Their portfolio includes the IGE-FAST test for rapid IgE detection, the THEOFAST test kit for theophylline measurement, and labeled anti-IgE reagents for research use. Additional offerings include the CHYMOFAST test for chymotrypsin assessment and serum-based IgE testing for clinical diagnostics.
The company’s diagnostic devices are regulated under FDA Class I and Class II classifications, with several products cleared via the 510(k) pathway. These tests are intended for laboratory use and are listed in the FDA’s 510(k) database. Allergenetics operates from the United States.
Catalogue
Total Ige Fast Test Ref K834594
Regimes: 510(k) Registry: 510(k)Allergenetics Ige Fast Test Ref K851512
Regimes: 510(k) Registry: 510(k)Allergenetics Ige-Fast Test Ref K822341
Regimes: 510(k) Registry: 510(k)Theofast Test Kit For Quantitative Theo Ref K834244
Regimes: 510(k) Registry: 510(k)Allergenetics Aller-Specific Ige Serum Ref K842969
Regimes: 510(k) Registry: 510(k)Allergentics Total Ige/Theophylline Ref K842970
Regimes: 510(k) Registry: 510(k)Labeled 125I Anti-Ige Ref K833419
Regimes: 510(k) Registry: 510(k)Chymofast Test Ref K833418
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Allergenetics have in the registry?
The registry currently lists 8 devices for Allergenetics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Allergenetics's devices?
Among its 8 most recently registered devices, Allergenetics has devices listed in FDA 510(k) (8 devices).
What risk classes do Allergenetics's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Allergenetics's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Allergenetics in the registry?
The most recently registered devices listed for Allergenetics include TOTAL IGE FAST TEST, ALLERGENETICS IGE FAST TEST, ALLERGENETICS IGE-FAST TEST and THEOFAST TEST KIT FOR QUANTITATIVE THEO.