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Zdrowie i gospodarka · 30/09/2004

FDA Proposes Reclassification of Hepatitis A Virus Serological Assays

The Food and Drug Administration (FDA) is proposing to reclassify hepatitis A virus (HAV) serological assays from Class III to Class II, allowing for greater flexibility in clinical laboratory testing for acute and past infections, following a petition from Beckman Coulter, Inc.

Source: Federal Register — Food and Drug AdministrationOpen original release →