Axis-Shield
United KingdomFDA 510(k) applicant, unverified
- Devices
- 3
What Axis-Shield makes
Axis-Shield makes the DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600, which is a diagnostic test device for detecting anti-cardiolipin antibodies of the IgG and IgM isotypes.
This device is classified as Class II and is listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
Diastat Anti-Cardiolipin Iga, Model Fcar 500 Ref K001981
510(k) 510(k)- 510(k) 510(k)
Diastat Anti-Cardiolipin Igg/Igm, Model Fcar 600 Ref K001574
510(k) 510(k)
Frequently asked questions
How many devices does Axis-Shield have in the registry?
The registry currently lists 3 devices for Axis-Shield. Devices recorded under merged duplicate company entries are counted once.
Which registries list Axis-Shield's devices?
Among its 3 most recently registered devices, Axis-Shield has devices listed in FDA 510(k) (3 devices).
What risk classes do Axis-Shield's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Axis-Shield's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Axis-Shield in the registry?
The most recently registered devices listed for Axis-Shield include DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500, ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY and DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600.