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BD Tritest CD3/CD4/CD45 With BD Trucount Absolute Count Tubes, Model 340402

by Bd Biosciences

510(k) K071141

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 · Special NumberK071141 Date6 Jun 2007ClearedStatusActive

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  • Withdrawn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, 6 Oct 2026

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

The BD Tritest CD3/CD4/CD45 with BD Trucount Absolute Count Tubes is a three-color direct immunofluorescence reagent system. It is designed for use with a flow cytometer to identify and determine the percentages and absolute counts of mature human T lymphocytes and helper/inducer T-lymphocyte subsets in erythrocyte-lysed whole blood.

This device is supplied for professional use in clinical settings. It has received FDA 510(k) clearance under regulation number 864.5220 for use as a differential cell counter.

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