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Zdrowie i gospodarka · 09/08/2011

FDA Releases Guidance on Herpes Simplex Virus Serological Assays

The Food and Drug Administration (FDA) has released a guidance document outlining the requirements for serological assays to test for Herpes Simplex Virus Types 1 and 2, a class II medical device. The document aims to ensure compliance with FDA regulations for these specific assays.

Source: Federal Register — Health and Human ServicesOpen original release →