Quantimetric 2 C-Reactive Protein Reag.

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K821984 ↗

FDA Product Code

DCK

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 Kallestad Laboratories, Inc. →

• What is the purpose of the Quantimetric 2 C-Reactive Protein Reagent?

  This immunological test system measures C-reactive protein in serum and other body fluids using immunochemical techniques to help evaluate the amount of injury to body tissues.

• How is the Quantimetric 2 C-Reactive Protein Reagent supplied?

  The device is supplied as a reagent system and is classified as Class II under special controls.

• What is the regulatory status of this device?

  The device is authorized under FDA 510(k) clearance with product code DCK and is manufactured by Kallestad Laboratories, Inc.

• What types of samples can be tested with this reagent system?

  The Quantimetric 2 C-Reactive Protein Reagent can be used to measure C-reactive protein in serum and other body fluids.