Cyto-Stat Trichrome CD45-FITC/CD19-RD1/CD3-PC5 Monoclonal Antibody Reagent with CD45-FITC/MSIGG1-RD1

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

Full name

Cyto-Stat Trichrome CD45-Fitc/CD19-RD1/CD3-PC5 Monoclonal Antibody Reagent with Cyto-Stat Trichrome CD45-Fitc/MSIGG1-RD1

510(k) Number

K982167 ↗

FDA Product Code

GKZ

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• What clinical applications is this monoclonal antibody reagent primarily used for in flow cytometry?

  This reagent is designed for flow cytometric analysis to simultaneously identify CD45, CD19, and CD3 cell surface markers on white blood cells. It aids in hematological diagnostics by enabling multi-color immunofluorescent staining, which helps differentiate and count specific white blood cell subsets, such as lymphocytes (B-cells via CD19, T-cells via CD3) and leukocytes (via CD45). This is particularly useful for diagnosing and monitoring hematological conditions.

• Is this reagent intended for single-use or can it be reused in multiple tests?

  The reagent is explicitly supplied as a ready-to-use solution for single-use in clinical hematology laboratories. Reuse is not recommended or authorized, as it could compromise accuracy, sterility, or performance in flow cytometry workflows.

• What regulatory pathways does this device follow, and how does it classify under FDA and IVD regulations?

  The reagent is authorized under FDA 510(k) clearance (K982167) and the In Vitro Diagnostic Device Directive (IVDD), classifying it as a Class II device under FDA category 864.5220 (Differential Cell Counter). It was determined substantially equivalent to a predicate device, with the Hematology (HE) advisory committee reviewing its submission.

• Does this reagent require special storage conditions, and is it sterile?

  The provided data does not specify sterility requirements or special storage conditions (e.g., temperature, light exposure) for this reagent. However, as a ready-to-use solution for clinical diagnostics, standard laboratory storage practices (e.g., refrigeration if applicable) should be followed to maintain integrity until use. Always refer to the manufacturer’s instructions for precise handling.

• Are there multiple sizes or models of this reagent available, or is it supplied in a single formulation?

  The data does not mention variations in sizes or models for this specific reagent. It is described as a single formulation—a ready-to-use monoclonal antibody reagent for multi-color flow cytometry—intended for direct immunofluorescent staining of CD45, CD19, and CD3 markers. No additional variants (e.g., different concentrations or volumes) are referenced.