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Monoclonal Antibody IGG2A Isotype Cont. Flow Cytom

by Gen Trak, Inc.

510(k) K922085

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 NumberK922085 Date28 Jul 1992ClearedStatusActive

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  • Withdrawn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, 1 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 device is a monoclonal antibody of the IgG2a isotype designed as an isotype control for flow cytometry. Isotype controls are essential reagents in flow cytometry, providing a baseline fluorescence signal to distinguish specific antibody binding from non-specific binding. This device is used in hematological research to validate experimental results by serving as a negative control.

This monoclonal antibody is supplied as a reagent for laboratory use in flow cytometry, intended for single-use applications in research settings. It is regulated under FDA 510(k) clearance (K922085) and classified as a Class II device (GKZ). The device is not sterile for clinical use and is intended for research settings only.

Other devices from Gen Trak, Inc.

Questions

AI-generated answers, 1 Oct 2026

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

  • What is the IgG2a isotype control antibody used for in flow cytometry?

    This monoclonal antibody IgG2a isotype control is used as a negative control in flow cytometry to establish a baseline fluorescence signal. It helps researchers distinguish specific antibody binding from non-specific binding, ensuring accurate validation of experimental results in hematological research.

  • Is this antibody suitable for clinical diagnostic use?

    No, this monoclonal antibody is explicitly intended for research settings only. It is not sterile for clinical use and should not be used in diagnostic or patient care environments.

  • How is the IgG2a isotype control antibody supplied, and is it single-use?

    The antibody is supplied as a reagent for laboratory use and is designed for single-use applications. This ensures consistency and reliability in research workflows, as reuse could compromise accuracy.

  • What regulatory clearance does this antibody hold?

    This device holds FDA 510(k) clearance under the reference number K922085, classified as a Class II medical device (product code GKZ). It was reviewed by the Hematology (HE) Advisory Committee and determined to be substantially equivalent to a predicate device.

  • Can this antibody be stored for long-term use, and are there specific storage instructions?

    While the device data does not specify storage conditions, monoclonal antibodies like this typically require refrigeration (2–8°C) to maintain stability. Always follow the manufacturer’s instructions for optimal storage and handling to preserve functionality.