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Abbott Cell-Dyn 4000 Immunopit (CD61) Assay

by Abbott Laboratories 510(k)

Active United States

510(k) K981342

Overview

The Abbott Cell-Dyn 4000 Immunopit (CD61) Assay is a counter, differential cell device used in hematology. It is designed for the detection and quantification of CD61-positive cells in blood samples.

This assay is supplied as a reagent for use with the Abbott Cell-Dyn 4000 hematology analyzer. It is intended for in vitro diagnostic use and has received FDA 510(k) clearance under product code GKZ and regulation number 864.5220.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK981342 Date29 Jun 1998ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-0648-03 FDA Unclassified (pre-2012) initiated 16 Oct 2002

    Product elicits fluorescent signal interference due to contamination.

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

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Questions

  • What is the Abbott Cell-Dyn 4000 Immunopit (CD61) Assay used for?

    The Abbott Cell-Dyn 4000 Immunopit (CD61) Assay is used for the detection and quantification of CD61-positive cells in blood samples as part of hematology analysis on the Abbott Cell-Dyn 4000 hematology analyzer.

  • How is the Abbott Cell-Dyn 4000 Immunopit (CD61) Assay supplied and what is required for its use?

    The assay is supplied as a reagent specifically designed for use with the Abbott Cell-Dyn 4000 hematology analyzer and requires this instrument to perform the detection and quantification of CD61-positive cells in vitro.

  • Is the Abbott Cell-Dyn 4000 Immunopit (CD61) Assay intended for single-use or reusable application?

    The Abbott Cell-Dyn 4000 Immunopit (CD61) Assay is supplied as a reagent for in vitro diagnostic use, indicating it is intended for single-use application with the Abbott Cell-Dyn 4000 analyzer to ensure accurate and reliable detection of CD61-positive cells.