Zdrowie i gospodarka · 25/08/2009

FDA Proposes Amendment to Device Classification Regulations for Herpes Simplex Virus Serological Assays

The Food and Drug Administration (FDA) is proposing to correct its device classification regulations by removing a reference to herpes simplex virus (HSV) serological assays other than types 1 and 2, as the only preamendments assays FDA was aware of were type 1 and type 2.