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Home » FDA Reclassifies Herpes Virus Assays as Class II Devices
FDA Reclassifies Herpes Virus Assays as Class II Devices
February 2, 2006
Serological assays for the detection of herpes simplex virus 1 and 2 (HSV 1 and 2) may fall under the requirements of special controls for Class II devices, according to an FDA draft guidance document.