Vancouver Biotech, Ltd.
Country not established
- Devices
- 2
What Vancouver Biotech, Ltd. makes
Vancouver Biotech, Ltd. manufactures in vitro diagnostic devices for measuring cardiac troponin I levels in human serum or plasma. These include immunoassay test kits and a dedicated serum test model designed to detect cardiac biomarkers for potential heart injury assessment.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. These devices are intended for use in clinical settings and are registered with the U.S. Food and Drug Administration.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Vbl Serum Troponin I Test, Model 1001 Ref K023505
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Vancouver Biotech, Ltd. have in the registry?
The registry currently lists 2 devices for Vancouver Biotech, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vancouver Biotech, Ltd.'s devices?
Among its 2 most recently registered devices, Vancouver Biotech, Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Vancouver Biotech, Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Vancouver Biotech, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Vancouver Biotech, Ltd. in the registry?
The most recently registered devices listed for Vancouver Biotech, Ltd. include VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST KIT and VBL SERUM TROPONIN I TEST, MODEL 1001.