GQH · Class II · 21 CFR 866.3175

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

Leading manufacturers include Medical Diagnostic Technologies, Inc., Syva Co. and Ortho Diagnostic Systems, 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 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 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

About Product Code GQH - Regulatory Context