Drugs Controller General revises specification of acceptance for quality test for Anti-HCV (Rapid Kit)

Drugs Controller General revises specification of acceptance for quality test for Anti-HCV (Rapid Kit)

July 24, 2017 Industry Specific 0

By way of a corrigendum dated 12th July, 2017, the  Drugs Controller General (“DCGI”) has revised the criteria of Sensitivity of Rapid Anti-HCV diagnostic kit, from99% to > 99% and has retained the present acceptance criteria of the other immunodiagnostic kits.

This corrigendum pertains to an Office Order dated 13th June, 2017, where the DCGI had revised the specification / criteria of acceptance for quality test for HIV-1 &/ or 2-Ab, HIV-1p24 Ag, HCV-Ab and HBsAg kits. The details of the Office Order is mentioned in the trail mail.

Source: Directorate General of Health Services

 

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