Chromogenix AB
Country not established
- Devices
- 4
What Chromogenix AB makes
Chromogenix AB manufactures chromogenic assay kits for coagulation testing, including resistance assays for activated protein C (APC), antithrombin, heparin, and protein C. These products are designed for laboratory use to measure blood clotting factors and monitor anticoagulant therapy.
The company’s portfolio is regulated as Class II medical devices in the US, with products listed via the FDA’s 510(k) pathway. Chromogenix AB is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Coacute Antithrombin R Chromogenic Assay Ref K952515
Regimes: 510(k) Registry: 510(k)Coacute Heparin Ref K952514
Regimes: 510(k) Registry: 510(k)Coamate Protein C Chromogenic Assay Ref K922201
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Chromogenix AB have in the registry?
The registry currently lists 4 devices for Chromogenix AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Chromogenix AB's devices?
Among its 4 most recently registered devices, Chromogenix AB has devices listed in FDA 510(k) (4 devices).
What risk classes do Chromogenix AB's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Chromogenix AB's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Chromogenix AB in the registry?
The most recently registered devices listed for Chromogenix AB include COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S, COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY, COACUTE HEPARIN and COAMATE PROTEIN C CHROMOGENIC ASSAY.