Cyto-Stat Trichrome CD8-Fitc/CD4-Rdi/CD3-PC5 Monoclonal Antibody Reagent with Cyto-Stat Trichrome Msiggi-Fitc/Msiggi-RD1

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

510(k) Number

K964618 ↗

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 specific cell types can this reagent identify and count simultaneously in a flow cytometry analysis?

  This reagent is designed for the simultaneous identification and enumeration of CD3+, CD4+, and CD8+ lymphocyte subsets, as well as dual-positive populations (CD3+/CD4+ and CD3+/CD8+). The three conjugated monoclonal antibodies—CD8-FITC, CD4-RD1, and CD3-PC5—enable multi-parametric analysis to distinguish these cell types in hematological samples.

• Is this reagent intended for reuse, or is it meant to be used only once per sample?

  The reagent is explicitly labeled for single-use only, requiring no additional preparation beyond the specified dilution in the instructions. This ensures optimal performance and sterility for each flow cytometry analysis.

• How should this reagent be stored, and are there any special handling requirements?

  Storage follows standard laboratory protocols for fluorescent reagents. While the data does not specify exact conditions, typical guidelines for such reagents include refrigeration (2–8°C) and protection from light to preserve fluorochrome integrity. Always refer to the accompanying instructions for precise storage details.

• What regulatory pathways does this device follow, and what medical specialty is it authorized for?

  The reagent is authorized under FDA 510(k) clearance (K964618) and classified as an In Vitro Diagnostic Device (IVDD). It adheres to regulatory standards for hematology, as indicated by its advisory committee classification (HE) and medical specialty designation.

• Does this reagent require any dilution or preparation before use in flow cytometry?

  No additional preparation is required beyond dilution as specified in the accompanying instructions. The reagent is supplied as a ready-to-use solution, simplifying workflow for direct immunofluorescent staining in hematological flow cytometry applications.