QGNClass II

Lateral Flow Immunochromatography Assay For Host Infection Biomarkers

21 CFR 866.3230 / Microbiology

QGN is the FDA product code for Lateral Flow Immunochromatography Assay For Host Infection Biomarkers, a class II device type, regulated under 21 CFR 866.3230. FDA's definition for this code reads: "A device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections is identified as an in vitro device intended for the detection and qualitative measurement, quantitative measurement, or both of one or more non-microbial analytes in human clinical specimens...". As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 2021-08-11, and no recalls.

Classification record

Product code: QGN
Device name: Lateral Flow Immunochromatography Assay For Host Infection Biomarkers
FDA definition: A device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections is identified as an in vitro device intended for the detection and qualitative measurement, quantitative measurement, or both of one or more non-microbial analytes in human clinical specimens to aid in the assessment, identification, or both of a localized microbial infection when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings.
Regulation: 21 CFR 866.3230
Device class: Class II
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code QGN

By decision year

2 clearances under product code QGN with a decision year between 2019 and 2021, 2019 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code QGN by decision year
Year	Clearances
2019	1
2021	1

Applicants with the most clearances

Product code QGN

Applicants holding the most 510(k) clearances under product code QGN
Applicant	Clearances
CD Diagnostics, Inc	2

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code QGN

Recent recalls

Product code QGN

FDA records show no recalls under product code QGN.

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)