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DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent

by Beckman Coulter, Inc.

510(k) K162208

Active European Union and United States

CE IVDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K162208↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK162208 Date9 Jan 2017ClearedStatusActive
European UnionCE/IVDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

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

Overview

AI-generated summary, 18 Sep 2026

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

The DxC 700 AU Clinical Chemistry Analyzer is a nephelometric method device designed for the quantitative measurement of immunoglobulins, including Immunoglobulin G (IgG), Immunoglobulin A (IgA), and Immunoglobulin M (IgM). It operates within the category of clinical chemistry analyzers, providing automated immunoassay analysis for immunology applications.

This analyzer is intended for use in mid- to high-volume clinical laboratories and is supplied as a reusable instrument with single-use reagents. It is classified under FDA device class 2 and has received FDA 510K clearance and IVDR conformity. The device requires appropriate storage conditions and maintenance as outlined in its operational manual to ensure accurate and reliable performance.

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Questions

AI-generated answers, 18 Sep 2026

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

  • What types of immunoglobulins can the DxC 700 AU Clinical Chemistry Analyzer measure, and how does it perform these measurements?

    The DxC 700 AU Clinical Chemistry Analyzer is designed to quantitatively measure Immunoglobulin G (IgG), Immunoglobulin A (IgA), and Immunoglobulin M (IgM) using a nephelometric method. This automated immunoassay analyzer provides precise and reliable results for immunology applications, making it suitable for mid- to high-volume clinical laboratories.

  • Is the DxC 700 AU Clinical Chemistry Analyzer a reusable instrument, and what does this mean for reagent usage?

    Yes, the DxC 700 AU is a reusable instrument, meaning the analyzer itself is designed for repeated use in clinical settings. However, it requires single-use reagents for each test run, ensuring accuracy, sterility, and compliance with best practices for immunoassay analysis.

  • What regulatory pathways has the DxC 700 AU Clinical Chemistry Analyzer followed, and what does this imply for its use in clinical laboratories?

    The device has received FDA 510(k) clearance and IVDR conformity, indicating it meets regulatory standards for safety and performance in the U.S. and European markets. This clearance confirms its suitability for use in clinical laboratories for quantitative immunoglobulin measurements, adhering to stringent quality and reliability requirements.

  • How should the DxC 700 AU Clinical Chemistry Analyzer be stored to maintain its performance?

    The analyzer requires appropriate storage conditions as outlined in its operational manual to ensure accurate and reliable performance. While the manual details specific guidelines, typical considerations include protecting it from extreme temperatures, humidity, and physical damage, as well as following manufacturer-recommended maintenance protocols.