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Bartels Legionella Urinary Antigen Elisa Test

by Intracel Corp.

510(k) K991074

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK991074 Date21 Dec 1999ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-2292-2025 FDA Class II initiated 22 Jul 2025

    Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.

    • Terminated Z-0382-2022 FDA Class II initiated 11 Oct 2021

    Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay

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  • Withdrawn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
MJH
Device Class
Class II
Regulation
21 CFR Part 866.3300
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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