GQI · Class II · 21 CFR 866.3175

FDA Product Code GQI: Antiserum, Cf, Cytomegalovirus

Leading manufacturers include Gull Laboratories, Inc., Cordis Corp. and Behring Diagnostics, Inc..

18
Total
18
Cleared
217d
Avg days
1985
Since

FDA 510(k) Cleared Antiserum, Cf, Cytomegalovirus Devices (Product Code GQI)

18 devices
1–18 of 18
Cleared May 06, 1988
DETECTADOT SYSTEM 2000 CMV IGG TEST
K875159
Gull Laboratories, Inc.
Microbiology · 142d
Cleared Jul 20, 1987
ENZYGNOST ANTI-CMV IGG TEST
K863488
Behring Diagnostics, Inc.
Microbiology · 314d
Cleared Feb 02, 1987
CMV MICROASSAY
K864420
Diamedix Corp.
Microbiology · 84d
Cleared Jun 13, 1986
COR DOT CMV
K853989
Cordis Corp.
Microbiology · 259d
Cleared Nov 14, 1985
CMV TEST
K853137
Gull Laboratories, Inc.
Microbiology · 111d

About Product Code GQI - Regulatory Context