Home / Device Classification / GNT

GNT — Antigens, Ha (Including Ha Control), Influenza Virus A, B, C Class I

FDA Device Classification

Classification Details

Product Code
GNT
Device Class
Class I
Regulation Number
866.3330
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K950838zymetxVIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSESJune 17, 1996
K913828bd becton dickinson vacutainer systems preanalyticQTEST INFLUENZA ASeptember 23, 1991
K902609bd becton dickinson vacutainer systems preanalyticDIRECTIGEN FLU ASeptember 10, 1990
K780275flow laboratoriesINFLUENZA HA ANTIGEN A/USSRFebruary 28, 1978
K780272flow laboratoriesINFLUENZA HA ANTIGENFebruary 28, 1978