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GQW — Antigen, Cf, (Including Cf Control), Varicella-Zoster Class II

FDA Device Classification

Classification Details

Product Code
GQW
Device Class
Class II
Regulation Number
866.3900
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K070206diagnostic hybridsDIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000August 30, 2007
K990141light diagnosticsLIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295October 19, 1999
K964872viral antigensVZV ANTIGEN CONTROL SLIDESMarch 18, 1997
K942743viro researchVIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENTDecember 15, 1994
K912239bd becton dickinson vacutainer systems preanalyticVZVSCAN(TM) LATEX AGGUTINATION TESTJune 11, 1991
K903882viral antigensVARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGGDecember 4, 1990
K894622bion entVARICELLA ZOSTER VIRUSOctober 24, 1989
K843676institute virionVARICELLA/ZOSTER VIRUSSeptember 26, 1985
K841434zeus scientificVARICELLA-ZOSTER(IGG) IFA TESTApril 19, 1985
K802938orion diagnosticaVARICELLA-ZOSTER ANTIGENS & CONTROLSDecember 31, 1980