Herpes Simplex Virus Types 1 and 2 Serological Assays - Class II Special Controls Guidance for Industry and FDA Staff
Read the Special Controls Document
Issue Date: 08/09/2011
Issued By: Office of Medical Products and Tobacco, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Safety
This special controls guidance document was developed to support the reclassification of the herpes simplex virus types 1 and 2 (HSV 1 and 2) serological assays into class II.