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IFA 40: HEP-20-10

by Euroimmun US

510(k) K131791

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 NumberK131791 Date26 Feb 2014ClearedStatusActive

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  • Withdrawn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
DHN
Device Class
Class II
Regulation
21 CFR Part 866.5100
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 device is an Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, used in immunology testing. It is designed for the detection of antinuclear antibodies via indirect immunofluorescence assay using HEP-20-10 substrate.

It is supplied as a control antigen for in vitro diagnostic use, intended for laboratory settings. The device is classified as Class II under FDA regulation 866.5100 with product code DHN, and received traditional 510(k) clearance (K131791) on February 26, 2014, demonstrating substantial equivalence to a predicate device.

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Questions

AI-generated answers, 21 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 IFA 40: HEP-20-10 device used for?

    The IFA 40: HEP-20-10 is a control antigen designed for the detection of antinuclear antibodies through indirect immunofluorescence assay using HEP-20-10 substrate, intended for in vitro diagnostic use in laboratory settings.

  • How is the IFA 40: HEP-20-10 supplied?

    The device is supplied as a control antigen for in vitro diagnostic use, specifically designed for laboratory settings to assist in immunology testing for antinuclear antibodies.

  • What is the regulatory classification of the IFA 40: HEP-20-10?

    The IFA 40: HEP-20-10 is classified as Class II under FDA regulation 866.5100 with product code DHN, and received traditional 510(k) clearance (K131791) on February 26, 2014, demonstrating substantial equivalence to a predicate device.

  • Is the IFA 40: HEP-20-10 a single-use device or can it be reused?

    The device is supplied as a control antigen for in vitro diagnostic use, but the description does not specify whether it is designed for single-use or multiple uses, so this information should be confirmed with the manufacturer.