TBM-Reagent for T, B Cell & Monocytes

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K843062 ↗

FDA Product Code

LIZ

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from Bd Becton Dickinson Vacutainer Systems Preanalytic →

• What is the TBM-Reagent for T, B Cells & Monocytes used for?

  The TBM-Reagent is designed to identify and quantify T cells, B cells, and monocytes in blood samples. This aids in hematological analysis and immune monitoring, providing critical data for diagnostic evaluations in laboratory settings.

• How is the TBM-Reagent supplied and intended for use?

  The TBM-Reagent is supplied as a liquid reagent specifically for in vitro diagnostic use. It is intended exclusively for laboratory environments, where trained professionals can apply it to blood samples for accurate cell-type analysis.

• Is the TBM-Reagent single-use or reusable?

  The TBM-Reagent is intended for single-use only. This ensures sterility and consistency in results, as reuse could compromise accuracy or introduce contamination.

• What regulatory pathway does the TBM-Reagent follow?

  The TBM-Reagent is cleared under the FDA’s 510(k) pathway, specifically under clearance number K843062. It is classified as a Class II device, indicating it poses moderate risk and requires regulatory oversight to ensure safety and effectiveness.

• What type of blood sample analysis does this reagent support?

  This reagent supports the specific staining and detection of T lymphocytes, B cells, and monocytes in blood samples. These cell types play key roles in the immune system, making this reagent valuable for assessing immune function and diagnosing hematological conditions.