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Ot Igg Sorbent

by Organon Teknika Corp. 510(k)

Active United States

510(k) K934324

Overview

The OT IGG SORBENT is an immunology device used for the detection and quantification of immunoglobulin G (IgG) antibodies in laboratory testing. It functions as a sorbent material designed to bind and isolate IgG antibodies from sample specimens.

This device is supplied as a laboratory reagent and is intended for single-use in diagnostic procedures. It is regulated under FDA 510K clearance with product code DEW and is classified as Class II medical device. The device is manufactured by Organon Teknika Corp. and is not indicated for MRI compatibility.

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

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK934324 Date21 Apr 1994ClearedStatusActive

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

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DEW
Device Class
Class II
Regulation
21 CFR Part 866.5510
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the OT IGG SORBENT used for in laboratory testing?

    The OT IGG SORBENT is an immunology device designed to bind and isolate immunoglobulin G (IgG) antibodies from sample specimens, enabling their detection and quantification in diagnostic laboratory procedures.

  • How is the OT IGG SORBENT supplied and what is its intended use?

    This device is supplied as a laboratory reagent and is intended for single-use in diagnostic procedures. It functions as a sorbent material specifically designed for the isolation of IgG antibodies from sample specimens.

  • What is the regulatory classification of the OT IGG SORBENT?

    The OT IGG SORBENT is regulated under FDA 510K clearance with product code DEW and is classified as a Class II medical device. It is manufactured by Organon Teknika Corp. and is not indicated for MRI compatibility.

  • Are there different sizes or models of the OT IGG SORBENT available?

    The device data does not specify different sizes or models of the OT IGG SORBENT. It is described as a laboratory reagent for the detection and quantification of IgG antibodies, with details about its regulatory classification and manufacturer information.