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Ana Eia Diagnostic Test Kit

by The Binding Site, Ltd. 510(k)

Active United States

510(k) K004019

Overview

The Ana Eia Diagnostic Test Kit is an antinuclear antibody immunological test system. It consists of reagents used to measure autoimmune antibodies in serum, body fluids, and tissues that react with cellular nuclear constituents such as ribonucleic acid and deoxyribonucleic acid using immunochemical techniques.

This device is identified by FDA 510(k) number K004019. It is classified under regulation number 866.5100 within the immunology medical specialty.

AI-generated from registry data, 25 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 NumberK004019 Date15 Feb 2001ClearedStatusActive

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 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LJM
Device Class
Class II
Regulation
21 CFR Part 866.5100
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the primary purpose of the ANA EIA Diagnostic Test Kit?

    This test kit is an antinuclear antibody immunological system designed to measure autoimmune antibodies. It detects antibodies in serum, body fluids, and tissues that react with cellular nuclear constituents, specifically ribonucleic acid and deoxyribonucleic acid.

  • What technology does this test kit use?

    The kit utilizes immunochemical techniques to identify and measure the presence of specific autoimmune antibodies. It is categorized as an enzyme-labeled antinuclear antibody test system.

  • Is this device recognized by the FDA?

    Yes, this device is identified by FDA 510(k) number K004019. It is classified under regulation number 866.5100 within the immunology medical specialty.