Immulite High Sensitivity Crp, Immulite 2000 High Sensitivity Crp

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

510(k) Number

K003372 ↗

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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• What is the Immulite High Sensitivity CRP used for?

  The Immulite High Sensitivity CRP is designed to measure C-reactive protein (CRP) levels in serum or plasma. CRP is a biomarker used to evaluate systemic inflammation, infection, tissue injury, and inflammatory disorders. By detecting even low levels of CRP, this assay helps clinicians assess patients with suspected or confirmed inflammatory conditions.

• How is the Immulite High Sensitivity CRP supplied and intended for use?

  This device is supplied as a reagent kit specifically for the Immulite 2000 analyzer platform. It is intended for use exclusively in clinical laboratories to perform quantitative CRP measurements. The kit is part of an in vitro diagnostic immunoassay system, ensuring standardized and reliable results within a controlled laboratory setting.

• Is the Immulite High Sensitivity CRP single-use or reusable?

  The Immulite High Sensitivity CRP reagent components are single-use only. Each kit is designed for one-time use in the Immulite 2000 analyzer to maintain accuracy and prevent cross-contamination. Reagents must not be reused after opening or exposure to samples.

• What regulatory pathway does the Immulite High Sensitivity CRP follow?

  The Immulite High Sensitivity CRP holds a 510(k) clearance from the FDA, demonstrating substantial equivalence to a predicate device. It is classified under FDA regulation number 866.5270 for immunology assays and falls within Class II (moderate risk) devices. The clearance was granted by the Immunology (IM) Advisory Committee.

• Are there any special storage requirements for the Immulite High Sensitivity CRP reagent kit?

  While the device data does not specify exact storage conditions, reagent kits like this typically require storage at 2–8°C (36–46°F) to preserve stability and performance. Always refer to the included instructions for storage details, as improper handling could compromise assay accuracy. Ensure the kit remains protected from light and contamination.