Dengue NS1 ELISA kit - India CDSCO Medical Device Registration
Dengue NS1 ELISA kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000109_967e0317fdcfc395b491d145ffdc8534_f585e9435f9315a41ca9ea0421a179b2. The license holder is Levram Lifesciences Private Limited, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.
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License Holder
Levram Lifesciences Private LimitedDevice Class
Approving Authority
Central Drug Standards Control Organization, West Zone
Product Information
The Diagnostic Automation in Dengue NS1 ELISA for early detection of Dengue virus ##PLACEHOLDER_0##, is an ELISA assay system for the detection of NS1 antigen in human serum. This test will aid in the early diagnosis of Dengue virus in human serum even prior to the presence of IgM or IgG antibodies. It is not intended to screen blood or blood components and is for investigational use only. Not for use in diagnostic procedures
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