Mast Immunosystems
Country not established
- Devices
- 13
What Mast Immunosystems makes
Mast Immunosystems develops and manufactures in-vitro diagnostic devices for measuring immunoglobulin E (IgE) levels and allergen-specific IgE responses, including chemiluminescent and luminometric systems. Their portfolio includes systems for total IgE quantification, inhalant allergen profiling, and densitometric analysis of specific IgE antibodies, primarily for allergy diagnostics.
The company’s diagnostic devices are classified under FDA Class II and are authorised through the 510(k) clearance process. These products are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Search and filter all 13 devicesFrequently asked questions
How many devices does Mast Immunosystems have in the registry?
The registry currently lists 13 devices for Mast Immunosystems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mast Immunosystems's devices?
Among its 13 most recently registered devices, Mast Immunosystems has devices listed in FDA 510(k) (13 devices).
What risk classes do Mast Immunosystems's devices fall under?
Among its 13 most recently registered devices, the classes recorded for Mast Immunosystems's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mast Immunosystems in the registry?
The most recently registered devices listed for Mast Immunosystems include MAST CLA ALLERGY SYSTEM, INHALANT PROFILE-ALLERGEN-SPECIFIC IGE, MAST ALLERGY SYSTEM and CHEMILUMINESCENT SYSTEM ALLERGAN SPECIFIC IGE.