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National Institute of Biologicals

(राष्ट्रीय जैविक संस्थान)

Ministry of Health & Family Welfare,Government of India

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Disease Specific In-Vitro Diagnostic Laboratory

Immunodiagnostic Laboratory is notified as Central Drugs Laboratory (CDL) by Government of India vide Gazette No. G.F.R. 601 (E), dated 27th August 2002 for in-vitro diagnostic devices for HIV, HCV and HBsAg. Since 1997, Immunodiagnostic Laboratory has been conducting Quality evaluation of indigenously manufactured and imported kits (Rapid, ELISA, Confirmatory, Ag/Ab & Combo Kits) for HIV, HCV, HBsAg & syphilis which were forwarded by Central Drugs Standard Control Organization (CDSCO) and procurement division of NACO. The Immunodiagnostic Laboratory has a Quality Management System in place and is NABL Accredited for testing of Rapid, ELISA and Confirmatory Immunodiagnostic Kits HIV, HBV & HCV in accordance with the standard ISO/IEC17025; 2005 in the field of biological testing of diagnostic Kits vide Certificate No. T-2011 dated 06/06/2011. This ensures quality evaluation of diagnostic kits for safeguarding public health in the country.


Disease Specific In-Vitro Diagnostic Laboratory is also carrying out evaluation of molecular diagnostic test kits indented to be used for blood donor screening for Human Immunodeficiency virus (HIV), Hepatitis-B virus and Hepatitis-C virus. For evaluation of such kits the laboratory has developed plasma panels. Each plasma panel represents a dynamic range of viral load i.e. viral load in each panel varies from few copies to billion copies.




Notifications !!  


Acceptance Criteria for Test & Examination of Blood Glucose Test Strips as per ISO 15197:2013new


Turnaround time for testing new








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