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Axis Biochemicals, Asa

Also registered as Axis-Shield Biochemicals, Asa

Country not established

Devices
5

What Axis Biochemicals, Asa makes

Axis Biochemicals, Asa manufactures in vitro diagnostic devices, specifically the IMX Homocysteine and Axis Homocysteine Enzyme Immunoassay, along with modifications to the IMX Homocysteine device.

These devices are classified as Class II and are listed in the FDA 510(k) registry. The company is based in the US.

AI-generated from registry data, 30 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue5

Newest first, rows 1-5 of 5

  • Imx Homocysteine Ref K980812

    Class II
    Active 510(k) 510(k) II
  • Holotc Ria Ref K030655

    Class II
    Active 510(k) 510(k) II
  • Bio-Rad %cdt Tia Ref K001651

    Class I
    Active 510(k) 510(k) I
  • Axis Homocysteine Enzyme Immunoassay Ref K980907

    Class II
    Active 510(k) 510(k) II
  • Modification To Imx Homocysteine Ref K992274

    Class II
    Active 510(k) 510(k) II

Frequently asked questions

How many devices does Axis Biochemicals, Asa have in the registry?

The registry currently lists 5 devices for Axis Biochemicals, Asa. Devices recorded under merged duplicate company entries are counted once.

Which registries list Axis Biochemicals, Asa's devices?

Among its 5 most recently registered devices, Axis Biochemicals, Asa has devices listed in FDA 510(k) (5 devices).

What risk classes do Axis Biochemicals, Asa's devices fall under?

Among its 5 most recently registered devices, the classes recorded for Axis Biochemicals, Asa's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Axis Biochemicals, Asa in the registry?

The most recently registered devices listed for Axis Biochemicals, Asa include IMX HOMOCYSTEINE, HOLOTC RIA, BIO-RAD %CDT TIA and AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY.

Generated automatically from registry data and not verified by a human reviewer.