Skip to content

Quantex Ferritin

by Instrumentation Laboratory CO

510(k) K040879

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 NumberK040879 Date10 May 2004ClearedStatusActive

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  • Withdrawn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
DBF
Device class
Class II
Regulation
21 CFR Part 866.5340
Advisory committee
Immunology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

Quantex Ferritin is a device classified as a ferritin antigen, antiserum, and control. It is intended for use in establishing calibration curves and monitoring the quality control of results obtained with Quantex ferritin reagents by turbidity.

This device is regulated under FDA 510(k) clearance, which was granted on May 10, 2004, under the product code DBF. It is categorized as a Class II device within the immunology medical specialty.

Other devices from Instrumentation Laboratory Company

See all devices from Instrumentation Laboratory Company →

Questions

AI-generated answers, 26 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 primary purpose of the Quantex Ferritin device?

    This device is designed to function as a ferritin antigen, antiserum, and control. Its intended use is to establish calibration curves and monitor the quality control of results obtained when using Quantex ferritin reagents via turbidity methods.

  • How is this device regulated?

    Quantex Ferritin is regulated under FDA 510(k) clearance, which was granted on May 10, 2004, under the product code DBF. It is classified as a Class II medical device within the immunology specialty.

  • What is the regulatory classification of this product?

    The device is categorized as a Class II immunology device, identified by regulation number 866.5340. This classification reflects its role in clinical laboratory testing procedures.