510(k) K181334

ADVIA Centaur Herpes-2 IgG by Biokit, S.A. — Product Code MYF

K181334 is an FDA 510(k) premarket notification submitted by Biokit, S.A. for the device "ADVIA Centaur Herpes-2 IgG". The FDA issued a decision of Substantially Equivalent on August 23, 2018. The device falls under product code MYF (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2), a Class II device regulated under 21 CFR 866.3305. Biokit, S.A. has at least 10 other 510(k) clearances on record.