The Dpc Monoclonal Eia Total Ige Kit

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

510(k) Number

K852878 ↗

FDA Product Code

DGC

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• What is the Dpc Monoclonal Eia Total Ige Kit used for?

  The Dpc Monoclonal Eia Total Ige Kit is used for the quantitative measurement of total immunoglobulin E (IgE) in human serum, employing an enzyme immunoassay methodology with monoclonal antibodies to detect IgE antigen-antibody complexes in clinical immunology testing by trained professionals.

• How is the Dpc Monoclonal Eia Total Ige Kit supplied and what is its intended use?

  The kit is supplied as a reagent system for laboratory use and is intended for use by trained professionals in clinical immunology testing to quantitatively measure total IgE levels in human serum samples.

• What regulatory pathway was used for the Dpc Monoclonal Eia Total Ige Kit and what is its classification?

  The device was cleared under the FDA 510(k) pathway with K852878, classified as a Class II medical device with product code DGC and regulation number 866.5510, and determined to be substantially equivalent to a legally marketed predicate device.