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Rdi Hsferritin Kit

by Reference Diagnostics, Inc. 510(k)

Active United States

510(k) K053211

Overview

The RDI HSFERRITIN KIT is a device for quantitative measurement of ferritin in human serum or plasma. It is classified as a Ferritin, Antigen, Antiserum, Control product.

The device is supplied by Reference Diagnostics, Inc. and is authorized under FDA 510(k) clearance with product code DBF. It is a Class II device with special controls and was cleared on March 13, 2006.

AI-generated from registry data, 22 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 NumberK053211 Date13 Mar 2006ClearedStatusActive

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 6 Oct 2026.

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

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Questions

  • What is the RDI HSFERRITIN KIT used for?

    The RDI HSFERRITIN KIT is designed for the quantitative measurement of ferritin levels in human serum or plasma. Ferritin is a protein that stores iron and is commonly measured to assess iron stores in the body.

  • How is the RDI HSFERRITIN KIT supplied?

    The RDI HSFERRITIN KIT is supplied by Reference Diagnostics, Inc. It is classified as a Ferritin, Antigen, Antiserum, Control product and comes with the necessary components for quantitative measurement of ferritin in clinical samples.

  • What is the regulatory status of the RDI HSFERRITIN KIT?

    The RDI HSFERRITIN KIT is authorized under FDA 510(k) clearance with product code DBF. It is a Class II device with special controls and was cleared on March 13, 2006, making it substantially equivalent to other marketed devices.

  • Is the RDI HSFERRITIN KIT reusable or single-use?

    The device information does not specify whether the RDI HSFERRITIN KIT is reusable or single-use. This detail would typically be found in the product's instructions for use, which should be consulted for proper handling and disposal procedures.