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MCD — Antigen, Ebv, Capsid Class I

FDA Device Classification

Classification Details

Product Code
MCD
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
K984126zeus scientificTHE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYMJanuary 11, 1999
K933251virion (u.s.)EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TESTJune 13, 1994
K925689fuller laboratoriesMERIDIAN EBV-IGG TEST KITOctober 12, 1993
K924091zeus scientificEBV-VCA IGG ELISA TEST SYSTEMJanuary 11, 1993
K920412ortho diagnostic systemsMODIFIED ORTHO EBV VCA-IGG ELISAJune 22, 1992
K911570ortho diagnostic systemsEPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TESTJune 10, 1991
K911571ortho diagnostic systemsEPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TESTJune 10, 1991
K910872gull laboratoriesEBV IGG ELISA TESTApril 12, 1991