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Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays

Tue, 09/28/2010 - 1:31pm
U.S. Food & Drug Administration

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.

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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

 

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