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Mardx Lyme Disease IFA (IGM) Test System

by Mardx, Inc.

510(k) K894609

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK894609 Date19 Sep 1989ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
LSR
Device Class
Class II
Regulation
21 CFR Part 866.3830
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Mardx Lyme Disease IFA (IGM) Test System is a Borrelia serological reagent used for immunofluorescent assay testing. It is designed to detect IgM antibodies associated with Lyme disease infection. This test system is classified as a Class II medical device in the microbiology specialty.

The device is supplied as a test system for laboratory use and is not specified as single-use or reusable. It is regulated under FDA 510(k) clearance with product code LSR and has been assigned multiple registration numbers. The device is intended for use in clinical laboratory settings for the detection of Lyme disease antibodies.

Questions

AI-generated answers, 28 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 Mardx Lyme Disease IFA (IGM) Test System used for?

    The Mardx Lyme Disease IFA (IGM) Test System is a Borrelia serological reagent designed for immunofluorescent assay testing to detect IgM antibodies associated with Lyme disease infection in clinical laboratory settings.

  • How is the Mardx Lyme Disease IFA (IGM) Test System supplied?

    The device is supplied as a test system for laboratory use. It is not specified as single-use or reusable in the provided information.

  • What is the regulatory classification of the Mardx Lyme Disease IFA (IGM) Test System?

    The test system is classified as a Class II medical device in the microbiology specialty and is regulated under FDA 510(k) clearance with product code LSR. It has been assigned multiple registration numbers.

  • In what settings is the Mardx Lyme Disease IFA (IGM) Test System intended to be used?

    The device is intended for use in clinical laboratory settings for the detection of Lyme disease antibodies, as specified in its classification as a microbiology specialty medical device.