GOI — Antiserum, Fluorescent, Rabies Virus Class II

FDA Device Classification

FDA product code GOI covers "Antiserum, Fluorescent, Rabies Virus", a Class II medical device regulated under 21 CFR 866.3460. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
GOI
Device Class
Class II
Regulation Number
866.3460
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K972975light diagnosticsLIGHT DIAGNOSTICS RABIES DFA REAGENTDecember 22, 1998
K820499centocorFITC ANTI-RABIES MONOCLONAL GLOBULINApril 16, 1982