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GQH — Antigen, Cf (Including Cf Control), Cytomegalovirus Class II

FDA Device Classification

FDA product code GQH covers "Antigen, Cf (Including Cf Control), Cytomegalovirus", a Class II medical device regulated under 21 CFR 866.3175. Submissions are reviewed by the Microbiology panel. At least 19 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
GQH
Device Class
Class II
Regulation Number
866.3175
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K982311intracelBARTELS CINAKIT CMV ANTIGENEMIADecember 14, 1998
K964875viral antigensCMV ANTIGEN CONTROL SLIDESMarch 18, 1997
K935809light diagnosticsCYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAYMay 5, 1994
K882835stellar bio systemsINDIRECT FLUORESCENT ASSAY FOR (HCMV)December 5, 1988
K882024whittaker bioproductsFITC MURINE MONOCLONAL ANTI-CMV IGGAugust 3, 1988
K881932ortho diagnostic systemsORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENTAugust 1, 1988
K880679bion entBION CMV-G TEST SYSTEMJune 3, 1988
K880290syvaMICROTRAK CMV CULTURE CONFIRMATION TESTApril 19, 1988
K872576enzo biochemCOLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATIONDecember 4, 1987
K873114medical diagnostic technologiesCYTOMEGALOVIRUS CONTROL SLIDESSeptember 25, 1987
K864565serono diagnosticsMONABRITE CYTOMEGALOVIRUS (CMV) IFA KITFebruary 19, 1987
K843657institute virionCYTOMEGALOVIRUSSeptember 26, 1985
K833089clinical sciencesCYTOMEGALOVIRUS ANTIBODY FLUORO-KIT IIMay 2, 1984
K811671zeus scientificCYTOMEGALOVIRUS ANTIBODY TEST SYSTEMSeptember 16, 1981
K802930orion diagnosticaCYTOMEGALO VIRUS & CONTROLSJanuary 9, 1981
K801963immuno-diagnostic productsCMV TEST KITOctober 23, 1980
K801722litton bioneticsCMV BIO-BEAD TITRATION KITSeptember 16, 1980
K791948intl. diagnostic technologyFIAX TEST KIT FOR ANTI-CYTOMEGALORIRUSNovember 16, 1979
K791612litton bioneticsCMV BIO-BEAD SCREEN KITNovember 13, 1979

FDA data resources