Procalcitonin - India CDSCO Medical Device Registration

Procalcitonin is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000420_5767d3445dac8d6e124faebfdad2044a_93f2c6257b477cfe47420b21eb242a30. This device is marketed under the brand name Electro chemiluminescence Immunoassay. The license holder is M/S Agappe Diagnostics Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Procalcitonin

UID: IMP/IVD/2021/000420_5767d3445dac8d6e124faebfdad2044a_93f2c6257b477cfe47420b21eb242a30

Brand Name

Electro chemiluminescence Immunoassay

License Holder

M/S Agappe Diagnostics Ltd

Device Class

Class B

Approving Authority

CDSCO

Product Information

Immunoassay for the in vitro quantitative determination of PCT ( Electro chemiluminescence Immunoassay) in human serum and plasma. The results can be used to aid in the early detection of clinically relevant bacterial infections