FDA Product Code MYF: Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Leading manufacturers include Roche Diagnostics and Biokit, S.A..
FDA 510(k) Cleared Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 Devices (Product Code MYF)
About Product Code MYF - Regulatory Context
510(k) Submission Activity
10 total 510(k) submissions under product code MYF since 2000, with 10 receiving FDA clearance (average review time: 212 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under MYF have taken an average of 85 days to reach a decision - down from 226 days historically, suggesting improved FDA processing for this classification.
MYF devices are reviewed by the Microbiology panel. Browse all Microbiology devices →