← Back to catalogue

Ferritin Generation 2

FDA 510(k)

Class II (US FDA 510(k))

510(k) K031650

by Roche Diagnostics Corp.

Identifiers

510(k) Number
K031650 FDA 510(k)
FDA Product Code
DBF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5340 FDA 510(k)
Regulation Number
866.5340 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Ferritin Generation 2 is an in vitro diagnostic reagent system used for the quantitative determination of ferritin in human serum and plasma. It utilizes a particle-enhanced immunoturbidimetric assay where human ferritin in samples agglutinates with latex particles coated with anti-ferritin antibodies.

This device is intended for use on clinical chemistry analyzers and has received FDA 510(k) clearance. It is classified as a Class II medical device under the product code DBF.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: FERRITIN GENERATION 2 (K031650) — FDA 510 (k) | Innolitics, FERRITIN GENERATION 2 (K031650) - FDA 510 (k), Elecsys® Ferritin - Roche Diagnostics USA

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Roche Diagnostics Corp.

Sources (1)

  • FDA 510(k) K031650 24 fields · synced Sep 26, 2026