GNT · Class I · 21 CFR 866.3330

FDA Product Code GNT: Antigens, Ha (including Ha Control), Influenza Virus A, B, C

Leading manufacturers include Flow Laboratories, Inc., Bd Becton Dickinson Vacutainer Systems Preanalytic and Zymetx, Inc..

5
Total
5
Cleared
124d
Avg days
1978
Since

FDA 510(k) Cleared Antigens, Ha (including Ha Control), Influenza Virus A, B, C Devices (Product Code GNT)

5 devices
1–5 of 5
Cleared Jun 17, 1996
VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES
K950838
Zymetx, Inc.
Microbiology · 479d
Cleared Sep 23, 1991
QTEST INFLUENZA A
K913828
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 28d
Cleared Sep 10, 1990
DIRECTIGEN FLU A
K902609
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 90d
Cleared Feb 28, 1978
INFLUENZA HA ANTIGEN
K780272
Flow Laboratories, Inc.
Microbiology · 11d
Cleared Feb 28, 1978
INFLUENZA HA ANTIGEN A/USSR
K780275
Flow Laboratories, Inc.
Microbiology · 11d

About Product Code GNT - Regulatory Context