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Elisa Combi-Kit Human Igg Subclasses

by Janssen Research Foundation

510(k) K911610

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK911610 Date12 Jun 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
DEW
Device Class
Class II
Regulation
21 CFR Part 866.5510
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 ELISA COMBI-KIT HUMAN IGG SUBCLASSES is an immunology device used for the detection and measurement of human IgG subclasses. It is designed for laboratory use in diagnostic testing applications.

This kit is supplied as a single-use device and is not MRI compatible. It is manufactured by Janssen Research Foundation and has FDA 510K clearance with product code DEW. The device is stored according to manufacturer instructions and is regulated under 866.5510.

Questions

AI-generated answers, 21 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 is the ELISA COMBI-KIT HUMAN IGG SUBCLASSES used for?

    The ELISA COMBI-KIT HUMAN IGG SUBCLASSES is an immunology device designed for laboratory use in diagnostic testing applications. It is specifically used for the detection and measurement of human IgG subclasses in patient samples.

  • Is the ELISA COMBI-KIT HUMAN IGG SUBCLASSES a single-use device?

    Yes, the ELISA COMBI-KIT HUMAN IGG SUBCLASSES is supplied as a single-use device and is not intended for reuse. This ensures test integrity and prevents cross-contamination between samples.

  • What regulatory status does the ELISA COMBI-KIT HUMAN IGG SUBCLASSES have?

    The ELISA COMBI-KIT HUMAN IGG SUBCLASSES has FDA 510K clearance with product code DEW. It is regulated under 866.5510 and was determined to be substantially equivalent to other devices in its class.

  • How should the ELISA COMBI-KIT HUMAN IGG SUBCLASSES be stored?

    The ELISA COMBI-KIT HUMAN IGG SUBCLASSES should be stored according to the manufacturer's instructions. Proper storage conditions are essential to maintain the integrity and performance of the diagnostic components in the kit.