GSGClass I

Antisera, Fluorescent, All Types, Listeria Monocytogenes

21 CFR 866.3355 / Microbiology

GSG is the FDA product code for Antisera, Fluorescent, All Types, Listeria Monocytogenes, a class I device type, regulated under 21 CFR 866.3355. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: GSG
Device name: Antisera, Fluorescent, All Types, Listeria Monocytogenes
Regulation: 21 CFR 866.3355
Device class: Class I
Review panel: Microbiology
Submission type: 510(k) exempt
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 GSG.

Recent clearances

Product code GSG

FDA records hold no clearances under product code GSG.

Recent recalls

Product code GSG

Z-0798-2023Class IIAs the temperature and time out of range was exceeded, product performances cannot be guaranteedBiomerieux Inc / initiated 2022-11-09 / 10 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)