GQM — Antisera, Neutralization, Herpesvirus Hominis Class II

FDA Device Classification

FDA product code GQM covers "Antisera, Neutralization, Herpesvirus Hominis", a Class II medical device regulated under 21 CFR 866.3305. Submissions are reviewed by the Microbiology panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
GQM
Device Class
Class II
Regulation Number
866.3305
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K875367enzo biochemCOLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMVMarch 28, 1988
K810043vibacGOAT ANTI-HERPES SIMPLEX VIRUS TYPE IMay 15, 1981
K791397microbiological assocHERPES EIA TEST KITSeptember 24, 1979