Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays
For questions regarding this document contact Haja Sittana El Mubarak, Ph.D., Division of Microbiology Devices at 301-796-6193 or by email: HajaSittana.ElMubarak@fda.hhs.gov,
When final, this document will supersede the document of the same name dated April 3, 2007.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Office of In Vitro Diagnostic Device Evaluation and Safety
Division of Microbiology Devices