GRWClass II

Antisera, All Fluorescent, Leptospira Spp.

21 CFR 866.3350 / Microbiology

GRW is the FDA product code for Antisera, All Fluorescent, Leptospira Spp., a class II device type, regulated under 21 CFR 866.3350. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: GRW
Device name: Antisera, All Fluorescent, Leptospira Spp.
Regulation: 21 CFR 866.3350
Device class: Class II
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: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

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

Recent clearances

Product code GRW

FDA records hold no clearances under product code GRW.

Recent recalls

Product code GRW

FDA records show no recalls under product code GRW.

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)