Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM
AustriaFDA applicant, unverified
- Devices
- 1
What Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM makes
The company produces the Technozym ADAMTS13 Activity assay, a diagnostic test used to measure ADAMTS13 protease activity in plasma samples. This assay aids in the diagnosis and monitoring of thrombotic thrombocytopenic purpura (TTP) by quantifying enzyme levels linked to platelet function and coagulation disorders.
The assay falls under FDA Class II regulatory classification and is listed in the FDA 510(k) database. The manufacturer is based in the United States.
Catalogue
Technozym ADAMTS13 Activity Ref DEN230024
Regimes: De Novo Registry: De Novo
Frequently asked questions
How many devices does Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM have in the registry?
The registry currently lists 1 device for Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM. Devices recorded under merged duplicate company entries are counted once.
Which registries list Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM's devices?
Among its 1 most recently registered device, Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM has devices listed in FDA 510(k) (1 device).
What risk classes do Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM's devices fall under?
Among its 1 most recently registered device, the classes recorded for Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM in the registry?
The most recently registered devices listed for Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM include Technozym ADAMTS13 Activity.