CRP Slide Test Kit

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K840699 ↗

FDA Product Code

DCN

Device Class

Class II

Regulation

21 CFR Part 866.5270

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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See all devices from Difco Laboratories, Inc. →

• What is the CRP Slide Test Kit used for?

  The CRP Slide Test Kit is a slide agglutination assay designed for the qualitative and semiquantitative detection of C-Reactive Protein (CRP) in human serum, primarily used in immunology laboratory testing.

• How is the CRP Slide Test Kit supplied?

  The CRP Slide Test Kit is supplied as a complete kit for laboratory use, containing all necessary components for performing the slide agglutination assay to detect CRP in human serum samples.

• Is the CRP Slide Test Kit a single-use device?

  The device information does not specify whether the CRP Slide Test Kit is single-use or reusable, but it is described as a kit for laboratory use that includes components for performing the slide agglutination assay.

• What is the regulatory status of the CRP Slide Test Kit?

  The CRP Slide Test Kit is a Class II medical device cleared by the FDA under 510(k) K840699, with product code DCN, and is intended for use in immunology testing settings.