Product code GOI— Microbiology

FITC ANTI-RABIES MONOCLONAL GLOBULIN

Classification name
Antiserum, Fluorescent, Rabies Virus
Device class
Class 2
Regulation
21 CFR 866.3460
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

Market context for product code GOI

FDA has cleared 2 devices under product code GOI between 1982 and 1998, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code GOI

Recent clearances under product code GOI

Data sourced from openFDA. This site is unofficial and independent of the FDA.