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JRY — Antiserum, Fluorescent, Epstein-Barr Virus Class I

FDA Device Classification

Classification Details

Product Code
JRY
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
K042118zeus scientificATHENA MULTI-LYTE EBV IGG TEST SYSTEMApril 29, 2005
K900974stellar bio systemsINDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.April 16, 1990
K891785bion entBION EBV-G (VCA) TEST SYSTEMAugust 31, 1989
K884829hillcrest biologicalsEBV EARLY ANTIGEN (R+D)April 12, 1989
K822734gull laboratoriesEBV IGM TESTDecember 9, 1982
K822985litton bioneticsEBV-M KITDecember 3, 1982
K821849biotech research laboratoriesEBV-VCA ANTIBODY ASSAY KITAugust 12, 1982
K811262zeus scientificEPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTIMay 27, 1981
K780925litton bioneticsEB-VCA, TEST, ANTIBODY, FLUORESCENTJune 22, 1978