Endotoxin Activity Assay - India CDSCO Medical Device Registration
Endotoxin Activity Assay is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000078_5363367216ee95acf3e219b1968a3f75_a3fdecdd6e9669ac6ad4ac20c05e63f0. This device is marketed under the brand name EAA™. The license holder is Elete Biotech Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
EAA™
License Holder
Elete Biotech Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
The EAA™ is a rapid in vitro diagnostic test that utilizes a specific monoclonal antibody to measure the endotoxin activity in EDTA whole blood specimens.
