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/2020/000095_08b0eaac39200fa95137cf44690814dc_e0b4bc59dc4188900ce3fa4ce03ead61. This device is marketed under the brand name Sensit Rapid. The license holder is Ubio Biotechnology Systems Private Limited, and it is classified as Device Class Class C. The approving authority is Central Drug Standard Control Organisation, South Zone.

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CDSCO Registered

Class Class C

Dengue NS1 Rapid Test

UID: MFG/IVD/2020/000095_08b0eaac39200fa95137cf44690814dc_e0b4bc59dc4188900ce3fa4ce03ead61

Brand Name

Sensit Rapid

License Holder

Ubio Biotechnology Systems Private Limited

Device Class

Class C

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

Dengue NS1 Rapid Test Kit is a qualitative immune chromatographic assay for the detection of NS1 antigen produced against Dengue in humanserum/plasma. Dengue NS1 Rapid Test is only intended for initial screening and reactive samples should be confirmed by a supplemental assay such as ELISA