Skip to content

Interlab Immunofixation Test(s)

by Interlab S.R.L.

510(k) K033187

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 NumberK033187 Date19 Nov 2003ClearedStatusActive

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  • Withdrawn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
CFF
Device Class
Class II
Regulation
21 CFR Part 866.5510
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Immunofixation Test is an in vitro diagnostic device used for the qualitative separation and identification of abnormal immunoglobulins (IgG, IgM, IgA) and kappa and lambda light chains in human serum and concentrated urine. It incorporates the use of specific antisera to heavy and light chains to precipitate immunoglobulins following electrophoresis, providing a highly sensitive and specific method to detect and classify monoclonal immunoglobulins.

This test is supplied by Interlab S.R.L. and is intended for use in clinical laboratories. The device is a Class II medical device cleared by the FDA under 510(k) K033187, with product code CFF. It is designed for use with the G26 EASYFIX instrument, which allows for total primary tube automation of routine electrophoresis tests including serum immunofixation and urine proteins analysis.

Other devices from Interlab S.R.L.

Questions

AI-generated answers, 25 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 purpose of the Interlab Immunofixation Test?

    The Immunofixation Test is an in vitro diagnostic device used for the qualitative separation and identification of abnormal immunoglobulins (IgG, IgM, IgA) and kappa and lambda light chains in human serum and concentrated urine.

  • How is the Immunofixation Test supplied and what equipment is required?

    The test is supplied by Interlab S.R.L. and is designed for use with the G26 EASYFIX instrument, which allows for total primary tube automation of routine electrophoresis tests including serum immunofixation and urine proteins analysis.

  • What is the regulatory classification of the Immunofixation Test?

    The device is a Class II medical device cleared by the FDA under 510(k) K033187, with product code CFF. It is intended for use in clinical laboratories and has been determined to be substantially equivalent.

  • What types of samples can be analyzed with the Immunofixation Test?

    The test can analyze human serum and concentrated urine samples to detect and classify monoclonal immunoglobulins using specific antisera to heavy and light chains following electrophoresis.