GQH · Class II · 21 CFR 866.3175

FDA Product Code GQH: Antigen, Cf (including Cf Control), Cytomegalovirus

Leading manufacturers include Intl. Diagnostic Technology, Orion Diagnostica, Inc. and Zeus Scientific, Inc..

19
Total
19
Cleared
117d
Avg days
1979
Since

FDA 510(k) Cleared Antigen, Cf (including Cf Control), Cytomegalovirus Devices (Product Code GQH)

19 devices
1–19 of 19
Cleared Dec 14, 1998
BARTELS CINAKIT CMV ANTIGENEMIA
K982311
Intracel Corp.
Microbiology · 166d
Cleared Mar 18, 1997
CMV ANTIGEN CONTROL SLIDES
K964875
Viral Antigens, Inc.
Microbiology · 103d
Cleared May 05, 1994
CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY
K935809
Light Diagnostics
Microbiology · 154d
Cleared Aug 03, 1988
FITC MURINE MONOCLONAL ANTI-CMV IGG
K882024
Whittaker Bioproducts, Inc.
Microbiology · 78d
Cleared Aug 01, 1988
ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT
K881932
Ortho Diagnostic Systems, Inc.
Microbiology · 83d
Cleared Apr 19, 1988
MICROTRAK CMV CULTURE CONFIRMATION TEST
K880290
Syva Co.
Microbiology · 85d
Cleared Sep 25, 1987
CYTOMEGALOVIRUS CONTROL SLIDES
K873114
Medical Diagnostic Technologies, Inc.
Microbiology · 46d
Cleared Feb 19, 1987
MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT
K864565
Serono Diagnostics, Inc.
Microbiology · 92d
Cleared May 02, 1984
CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II
K833089
Clinical Sciences, Inc.
Microbiology · 233d
Cleared Sep 16, 1981
CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM
K811671
Zeus Scientific, Inc.
Microbiology · 93d
Cleared Jan 09, 1981
CYTOMEGALO VIRUS & CONTROLS
K802930
Orion Diagnostica, Inc.
Microbiology · 51d
Cleared Nov 16, 1979
FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS
K791948
Intl. Diagnostic Technology
Microbiology · 46d

About Product Code GQH - Regulatory Context