LGBClass III

Gonococcal Antibody Tests

21 CFR 866.3290 / Microbiology

LGB is the FDA product code for Gonococcal Antibody Tests, a class III device type, regulated under 21 CFR 866.3290. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: LGB
Device name: Gonococcal Antibody Tests
Regulation: 21 CFR 866.3290
Device class: Class III
Review panel: Microbiology
Submission type: PMA
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code LGB.

Recent clearances

Product code LGB

FDA records hold no clearances under product code LGB.

Recent recalls

Product code LGB

Z-2856-2011Potential for the housing of the arterial line Leukocyte Reduction Filter to separate before or during the priming procedure.Pall Corporation / initiated 2011-05-26 / 232 units

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)