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Neia-Ferritin Enzymeimmunassay Kit

by New England Immunology Assoc.

510(k) K790490

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 NumberK790490 Date23 Apr 1979ClearedStatusActive

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  • Withdrawn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, 23 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 NEIA-FERRITIN Enzymeimmunoassay Kit is an immunology device used for the quantitative determination of ferritin in human serum or plasma. This assay utilizes enzyme immunoassay technology to measure ferritin levels, which is a protein that stores iron in the body.

The kit is supplied as a single-use device and is intended for laboratory use only. It is regulated under FDA 510K clearance with device class 2 and product code DBF. The kit includes various components such as antigen, antiserum, and controls, with multiple registration numbers and fei numbers as specified in the authorization data.

Other devices from New England Immunology Assoc.

Questions

AI-generated answers, 23 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 NEIA-FERRITIN Enzymeimmunoassay Kit used for?

    The NEIA-FERRITIN Enzymeimmunoassay Kit is used for the quantitative determination of ferritin in human serum or plasma. Ferritin is a protein that stores iron in the body, and this assay helps measure its levels using enzyme immunoassay technology.

  • Is the NEIA-FERRITIN Kit single-use or reusable?

    The NEIA-FERRITIN Enzymeimmunoassay Kit is supplied as a single-use device and is intended for laboratory use only. It should not be reused for multiple tests to ensure accurate results and maintain sterility.

  • What components are included in the NEIA-FERRITIN Kit?

    The kit includes various components such as antigen, antiserum, and controls. It contains multiple registration numbers and FEI numbers as specified in the authorization data, ensuring proper identification and traceability of each component.

  • What is the regulatory status of the NEIA-FERRITIN Kit?

    The NEIA-FERRITIN Enzymeimmunoassay Kit is regulated under FDA 510K clearance with device class 2 and product code DBF. It has been determined to be substantially equivalent to other devices in its class.