Dengue NS1 Rapid Test - India CDSCO Medical Device Registration

Dengue NS1 Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000140_a0e9e4d381ee8fd2267ebb73b655a5ea_f22e210116cfc7ac7ee7713341cfb478. This device is marketed under the brand name Medlera. The license holder is Medlera Healthcare, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class C

Dengue NS1 Rapid Test

UID: MFG/IVD/2023/000140_a0e9e4d381ee8fd2267ebb73b655a5ea_f22e210116cfc7ac7ee7713341cfb478

Brand Name

Medlera

License Holder

Medlera Healthcare

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Dengue NS1 Rapid Test is a rapid immunochromatographic assay for the qualitative detection of NS1 antigen of Dengue virus in human whole blood, serum and plasma samples. The test is intended as an aid in the earlier diagnosis of dengue infection.