GQI · Class II · 21 CFR 866.3175

FDA Product Code GQI: Antiserum, Cf, Cytomegalovirus

Leading manufacturers include Amico Lab, Inc., Labsystems, Inc. and Gull Laboratories, 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 Jun 30, 1994
CMV EARLY ANTIGEN TEST
K942171
Neogenex
Microbiology · 56d
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 Oct 01, 1986
CYTOMEGALOVIRUS IGG EIA TEST KIT
K862705
Labsystems, Inc.
Microbiology · 77d
Cleared Jun 13, 1986
COR DOT CMV
K853989
Cordis Corp.
Microbiology · 259d
Cleared Feb 05, 1986
CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530
K854666
Clinical Sciences, Inc.
Microbiology · 76d
Cleared Jan 08, 1986
CYTOMEGALOVIRUS IGG EIA TEST KIT
K843189
Labsystems, Inc.
Immunology · 513d
Cleared Dec 06, 1985
AMIZYME-CMV KIT
K842529
Amico Lab, Inc.
Immunology · 526d
Cleared Dec 06, 1985
ANTI-CYTOMEGALOVIRUS KIT
K842661
Amico Lab, Inc.
Immunology · 514d
Cleared Nov 14, 1985
CMV TEST
K853137
Gull Laboratories, Inc.
Microbiology · 111d
Cleared Nov 07, 1985
CMV CF ANTIGEN
K853277
Hillcrest Biologicals
Microbiology · 94d

About Product Code GQI - Regulatory Context