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GNP — Antiserum, Cf, Epstein-Barr Virus Class I

FDA Device Classification

Classification Details

Product Code
GNP
Device Class
Class I
Regulation Number
866.3235
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K020706pan bio pty.EBV-VCA IGG ELISA TEST, MODEL EBG-100June 13, 2002
K020717pan bio pty.EBV V VCA IGM ELISA KIT MODEL# EBM-200June 13, 2002
K020707pan bio pty.EBV-EBNA IGG ELISA KIT, MODEL EBG-100June 13, 2002
K981829diamedixIS EBV-EBNA-1 IGG ELISA TEST SYSTEMFebruary 16, 1999
K981831diamedixIS EBV-EA-D IGG ELISA TEST SYSTEMFebruary 16, 1999
K901156granbioEIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUMSeptember 12, 1990
K883670electro-nucleonicsSEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VIApril 28, 1989
K884591hillcrest biologicalsEBV-VCA ANTIBODY (IGG)January 24, 1989
K880883immuno conceptsEBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT)August 30, 1988
K880885immuno conceptsEBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME)August 30, 1988
K871373diagnostic technologyEBV-CHECK(TM) TEST KIT (IGG)June 25, 1987
K861121microbiological researchTHE GOLDEN QUAD TEST (EBV)February 2, 1987
K864347granbioINDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCAFebruary 2, 1987
K863408diagnostic technologyEBV/VCA-CHECK(TM) ANTIGEN SLIDESNovember 28, 1986
K854207immuno-diagnostic productsEBV(EPSTEIN-BARR VIRUS) TEST KITApril 24, 1986
K853484biotech research laboratoriesINDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANTFebruary 5, 1986
K842662amico labANTI-EPSTEIN-BARR VIRUS KITDecember 12, 1985
K842530amico labAMIZYME-EBV TEST KITDecember 6, 1985
K810860electro-nucleonics laboratoriesENI ANTIBODY TO EPSTEIN-BARR VIRUSMay 5, 1981
K771062gull laboratoriesEBV TESTJuly 14, 1977