Biochemical Kits Laboraotry





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 : 2017 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).

The Central Government vide Gazette notification S.O. 2237(E) on 01st June 2018 has designated the laboratory as 'Central Medical Device Testing Laboratory' for carrying out test and evaluation of Glucose Test Strips and Fully Automated Analyzer Based Glucose Reagent. The laboratory head (Ms. Ajanta Sircar) is appointed as Medical Device Testing Officer by the Central Government in respect of Medical Device (i.e. Glucose test strips and fully automated analyser based glucose reagents) vide Gazette Notification S.O. 3400(E) dated 11th July 2018.