Quantimetric 2 Ceruloplasmin Assay

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K823107 ↗

FDA Product Code

DDB

Device Class

Class II

Regulation

21 CFR Part 866.5210

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• What is the Quantimetric 2 Ceruloplasmin Assay used for?

  The Quantimetric 2 Ceruloplasmin Assay is used to measure ceruloplasmin, an antigen, for immunology purposes, specifically in the diagnosis and study of related conditions.

• Is the Quantimetric 2 Ceruloplasmin Assay a single-use device?

  The device description does not explicitly state if it is for single-use or reuse, but it is classified as a class 2 device with a specific regulation number, indicating it has a defined use protocol.

• What is the regulatory status of the Quantimetric 2 Ceruloplasmin Assay?

  The Quantimetric 2 Ceruloplasmin Assay has been authorized with an FDA 510K clearance, described as Substantially Equivalent, indicating it has met specific regulatory requirements for its intended use.

• How is the Quantimetric 2 Ceruloplasmin Assay supplied?

  The device is supplied by Kallestad Laboratories, Inc., and its distribution and storage would follow standard protocols for immunological assays to maintain efficacy and safety.