Tritest Reagent CD3 FITC/CD16+CD56 PE/CD45 PerCP; With Trucount Absolute Count Tubes

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

510(k) Number

K971110 ↗

FDA Product Code

GKZ

Models / Variants

Tritest Reagent CD3 Fitc/CD16+CD56 Pe/CD45 Percp

with Trucount Absolute Count Tubes

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K970742 Active Cleared 22 Oct 1997

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  FDA 510(k) K040026 Active Cleared 10 Sep 2004

• Trucount Absolute Count Tubes/Counting Control Beads

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  FDA 510(k) K970836 Active Cleared 26 Aug 1997

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  FDA 510(k) K040725 Active Cleared 10 Sep 2004

• Multitest CD3/CD8/CD45/CD4

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  FDA 510(k) K974360 Active Cleared 11 Mar 1998

• Simultest CD3/Anti-Hla-Dr

  Class II

  FDA 510(k) K924587 Active Cleared 5 Aug 1993

See all devices from Becton Dickinson Immunocytometry Systems →

• What is the Tritest Reagent CD3 FITC/CD16+CD56 PE/CD45 PerCP with Trucount Absolute Count Tubes used for?

  This reagent system is used for immunophenotyping of human leukocytes by flow cytometry. It contains fluorescently labeled antibodies that bind to specific cell surface markers (CD3, CD16+CD56, and CD45), allowing for identification and quantification of different cell populations.

• How is the Tritest Reagent supplied and what is its intended use?

  The product is supplied as a kit containing reagents and tubes for absolute cell counting. It is intended for in vitro diagnostic use and is regulated as a Class II device by the FDA.

• What regulatory status does this product have?

  The Tritest Reagent CD3 FITC/CD16+CD56 PE/CD45 PerCP with Trucount Absolute Count Tubes received FDA 510(k) clearance in 1997 and is manufactured by Becton Dickinson Immunocytometry Systems.

• Is this device single-use or reusable?

  The device is supplied as a kit containing reagents and tubes for absolute cell counting. While the description doesn't explicitly state whether it's single-use or reusable, it's common for flow cytometry reagents to be single-use to ensure accurate results and prevent contamination.