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DAKO Mouse Anti-Human T-Cell, CD3/RPE-CY5, Clone UCHT1 & DAKO Mouse Anti-Human T-Cell, CD3/RPE, Clone UCHT1

by Dako Corp.

510(k) K991402

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK991402 Date21 Jun 1999ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GKZ
Device Class
Class II
Regulation
21 CFR Part 864.5220
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a counter, differential cell, specifically monoclonal mouse antibodies conjugated to RPE (R-phycoerythrin) or RPE-Cy5 for flow cytometric analysis. The antibodies target human T-cells via the CD3 antigen, enabling identification and quantification of CD3-positive cells in hematological samples. The two variants (RPE and RPE-Cy5) allow for dual-color labeling, facilitating simultaneous detection of T-cells under different fluorescence channels. These reagents are designed for use in flow cytometry to assess T-cell populations in both normal and pathological conditions, such as immunodeficiency disorders.

The device is supplied as a ready-to-use reagent for in vitro diagnostic use in clinical laboratories. It is intended for single-use only and requires no additional sterilization or reprocessing. The reagents are classified under FDA regulation 864.5220 and fall under Class II medical devices, with a Traditional 510(k) clearance granted by the FDA’s Hematology Expert Panel. Storage conditions are not specified in the data but typically involve refrigeration to maintain stability. The product is authorized for use in hematological diagnostics and is not MRI-compatible.

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