GQG · Class I · 21 CFR 866.3480

FDA Product Code GQG: Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus

Leading manufacturers include Abbott Laboratories, Becton, Dickinson & CO and Quidel Corp..

32
Total
32
Cleared
105d
Avg days
1977
Since
32 devices
25–32 of 32
Cleared Sep 16, 1986
ABBOTT RSV EIA
K862429
Abbott Laboratories
Microbiology · 82d
Cleared Jan 03, 1986
IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST
K854081
Boots-Celltech Diagnostics, Inc.
Microbiology · 88d
Cleared Dec 04, 1985
RESPIRATORY SYNCYTIAL VIRUS ID REAGENT
K853695
Viromed Laboratories, Inc.
Microbiology · 91d
Cleared Dec 31, 1980
RESPIRATORY SYNCYTIAL VIRUS ANTIGEN &
K802936
Orion Diagnostica, Inc.
Microbiology · 42d
Cleared May 20, 1977
RESP. SYNCYTIAL-FA LABELLHD (8-301-RF)
K770804
Flow Laboratories, Inc.
Immunology · 17d
Cleared May 20, 1977
RESP. SYNCYTIAL-FA LABELLED PRESERUM
K770808
Flow Laboratories, Inc.
Immunology · 17d