Clarification on Electro-Chemiluminescence Immunoassay kits

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..... ef Commissioners/Chief Commissioners of Customs/Customs (Preventive), All Principal Chief Commissioners/Chief Commissioners of Customs and Central Tax All Principal Commissioners/ Commissioners of Customs/Customs (Preventive) All Principal Commissioners/Commissioners of Customs and Central Tax Sir, Subject: Clarification on Electro-Chemiluminescence Immunoassay kits-Reg. In rel .....

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..... y Welfare(MoHFW). The significant points on which a clarification was sought from MoHFW and the response received are tabulated below S. No. Clarification sought Response from MOHFW 1. How is a CLIA diagnostic kit defined? What are the different parameters that need to fulfilled to be considered .....

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..... . Label Chemical Directly Involved in the Light Emission Reaction i. Enzyme Catalyzed Light Emission Reaction iii. Redox Reaction Mediated Light Emission Reaction (ECLIA). 3. If yes, what are the other technologies that are considered to be included within CLIA 4. Whether an ECLIA diagnostic kit that is .....

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..... the parameters on the basis of which it is concluded that CLIA and ECLIA are one and the same. 6. Whether CLIA and ECLIA kits can be considered the same and if the exemption granted to CLIA can be extended to ECLIA. Chemiluminescence lmmuno assay (CLIA) is a self sufficient kit which provides a sensitive, high throughput alternative to conve .....

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