IDKL became operational in 1995 to protect and safeguarding of the Indian population. Since then, it has been conducting quality checks on indigenously manufactured and imported serology kits, including Rapid, ELISA, Confirmatory, CLIA, and ELFA those meant for diagnosis of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Syphilis in human blood and / or its components. These kits are supplied to NIB by the Central Drugs Standard Control Organization (CDSCO) and its offices, the Procurement Division of NACO, and Various Government Agencies. The laboratory was notified as a Central Drugs Laboratory (CDL) by the Government of India through Gazette No. GFR 601(E), dated 27th August, 2002, for diagnostic kits for HIV, HCV, and HBsAg. It was re-notified as a Central Drugs Laboratory (CDL) through GFR 908(E), dated 22th December, 2014. Subsequently, the In-Vitro Diagnostics Laboratory for Human Immunodeficiency Virus, Hepatitis B Surface Antigen and Hepatitis C Virus was notified as Central Medical Devices Testing Laboratory (CMDTL) by the Government of India vide Gazette No. S.O. 2237(E), dated 01st June, 2018.

The laboratory has been regularly participating in the international PT/EQAS for serology since 1999. Since 2000, the Immunodiagnostic Kit Laboratory has been designated as a National Reference Laboratory (NRL) by the National AIDS Control Organization (NACO), India, and has been monitoring two states, Uttar Pradesh and Uttarakhand, to strengthen HIV testing. The laboratory regularly supplies sera panels to domestic manufacturers to strengthen the quality of their domestically produced kits. The laboratory has a quality management system and is NABL accredited according to the standard ISO/IEC 17025:2017 for HIV-Ab, HCV-Ab, HBsAg, and syphilis serology.

As per another mandate of NIB, the laboratory is also regularly providing hands-on-training to healthcare professionals, academics, regulators, graduate students and/or post graduate students from various universities/institutes etc.