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(राष्ट्रीय जैविक संस्थान)

Ministry of Health & Family Welfare

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Biochemical Kit Lab Biochemical Kits Lab


Biochemical Kits Lab


The Biochemical Kits Laboratory is engaged in the evaluation of batches of Self-Monitoring of Blood Glucose (SMBG/ Glucometers) specific- Blood Glucose test Strips and fully automated analyzer based Glucose reagent. The Laboratory has referred to the Clinical Laboratory Standards Institute (CLSI) guidelines, International Standards Organization (ISO) 15197 : 2003 guidelines and the WHO: Laboratory Diagnosis and Monitoring of Diabetes Mellitus, 2002 for the procedures, statistical analysis of data and specifications of test parameters; precision, accuracy, linearity, and range. The particulars of testing and the 'Acceptance Criteria' have been vetted by the National Experts Committee. NABL accreditations of Biological and Chemical tests: BKL has been assessed and accredited in acoordance with the standard ISO/IEC 17025 : 2005 for QC testing of its two products viz. Blood Glucose Test Strips and Glucose Reagent.

   The laboratory has been notified as Central Drug Laboratory (C.D.L) and Laboratory Head (Ms. Ajanta Sircar) declared as Govt. Analyst for the class of drugs (i.e. Blood glucose test strips and fully automated analyzer based glucose reagents).




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


Turnaround time for testing new







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