Axis-Shield Doc AS
Country not established
- Devices
- 1
What Axis-Shield Doc AS makes
Axis-Shield Doc AS manufactures the COATEST® APC™ Resistance test, a diagnostic device used to detect antibiotic resistance in bacterial infections by identifying specific genetic markers in pathogens.
The company’s portfolio is regulated under FDA Class II devices and requires 510(k) clearance. The device is listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Coatest(R) Apc(Tm) Resistance Ref K945940
510(k) 510(k)
Frequently asked questions
How many devices does Axis-Shield Doc AS have in the registry?
The registry currently lists 1 device for Axis-Shield Doc AS. Devices recorded under merged duplicate company entries are counted once.
Which registries list Axis-Shield Doc AS's devices?
Among its 1 most recently registered device, Axis-Shield Doc AS has devices listed in FDA 510(k) (1 device).
What risk classes do Axis-Shield Doc AS's devices fall under?
Among its 1 most recently registered device, the classes recorded for Axis-Shield Doc AS's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Axis-Shield Doc AS in the registry?
The most recently registered devices listed for Axis-Shield Doc AS include COATEST(R) APC(TM) RESISTANCE.