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Igg Flex Reagent Cartridge

by Dade Behring, Inc. 510(k)

Active United States

510(k) K990551

Overview

The IGG FLEX REAGENT CARTRIDGE is a reagent cartridge used in the Dimension clinical chemistry system to quantitatively measure immunoglobulin G (IgG) in human serum and plasma. It is classified as a Radioimmunoassay for Immunoglobulins (G, A, M).

This device is supplied as a cartridge for use in clinical chemistry systems. It is a Class II device with special controls, cleared by the FDA on March 25, 1999 under 510(k) number K990551. The device is manufactured by Dade Behring, Inc. and is intended for in vitro diagnostic use.

AI-generated from registry data, 19 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 NumberK990551 Date25 Mar 1999ClearedStatusActive

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 22 Oct 2026.

Specification

510(k)

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

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Questions

  • What clinical chemistry system is the IGG FLEX REAGENT CARTRIDGE designed to work with, and what does it measure?

    The IGG FLEX REAGENT CARTRIDGE is specifically designed for use in the Dimension clinical chemistry system. It is used to quantitatively measure immunoglobulin G (IgG) levels in human serum and plasma, functioning as a reagent cartridge within that system.

  • Is the IGG FLEX REAGENT CARTRIDGE intended for single-use or reusable applications?

    The IGG FLEX REAGENT CARTRIDGE is intended for single-use only, as it is a reagent cartridge supplied for in vitro diagnostic testing. Reuse is not supported or recommended by the manufacturer.

  • What regulatory pathway was followed for FDA clearance of this device, and when was it cleared?

    The IGG FLEX REAGENT CARTRIDGE was cleared through the traditional 510(k) pathway by the FDA on March 25, 1999, under 510(k) number K990551. It was determined to be substantially equivalent to a predicate device and falls under the Immunology advisory committee (IM).

  • What are the key product codes and regulatory classifications associated with this device?

    The IGG FLEX REAGENT CARTRIDGE is classified under product code CFQ and is categorized as a Class II device with special controls. It is also associated with OpenFDA registration numbers (e.g., 3005670738, 3010825766) and falls under the radioimmunoassay for immunoglobulins (G, A, M) regulatory framework (regulation number 866.5510).