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In this section: Guidance Documents (Medical Devices and Radiation-Emitting Products)

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.

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