Legionella IgG/IgM ELISA Test System

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K963318 ↗

FDA Product Code

LHL

Device Class

Class II

Regulation

21 CFR Part 866.3300

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• What is the purpose of the Legionella IgG/IgM ELISA Test System?

  The Legionella IgG/IgM ELISA Test System is an in vitro diagnostic device designed for the qualitative detection of total IgG/IgM antibodies to Legionella pneumophila (serogroups 1-6) in patient serum, aiding in the diagnosis of Legionella infections.

• How is the Legionella IgG/IgM ELISA Test System supplied and used?

  The test system is supplied as a kit and is intended for single-use in clinical laboratory settings. It utilizes antigen-coated microtiter wells to capture specific antibodies, which are then bound by enzyme-labeled anti-human IgG/IgM conjugate, with results determined by photometric measurement after substrate addition.

• What are the storage requirements and regulatory status of this test system?

  The device requires appropriate storage conditions as specified by the manufacturer and is not MRI safe. It has received FDA 510(k) clearance with product code LHL and is classified as Class II under regulation number 866.3300.

• What Legionella serogroups does this test detect?

  The Legionella IgG/IgM ELISA Test System is designed for the qualitative detection of total IgG/IgM antibodies to Legionella pneumophila across serogroups 1-6, providing comprehensive detection for diagnostic purposes.