Dengue NS1Ag +IgG/IgM Combo - India CDSCO Medical Device Registration

Dengue NS1Ag +IgG/IgM Combo is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000055_f5196b09d2b17fc72e2b3f4bdf086efa_39137e31b4817f0ebf918b349defa142. This device is marketed under the brand name RAPHA SERO. The license holder is M/s Rapha Diagnostics PVt. Ltd.,, 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 NS1Ag +IgG/IgM Combo

UID: MFG/IVD/2021/000055_f5196b09d2b17fc72e2b3f4bdf086efa_39137e31b4817f0ebf918b349defa142

Brand Name

RAPHA SERO

License Holder

M/s Rapha Diagnostics PVt. Ltd.,

Device Class

Class C

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

N'SURE Dengue NS1Ag +IgG/IgM Combo is a rapid, qualitative immunochromatographic assay for the detection of dengue virus NS1 antigen and antibodies to Dengue virus (RAPHA SERO) in human serum or plasma. The N'SURE Dengue NS1Ag+IgG/IgM Combo Rapid Test is only intended for initial screening and reactive samples should be confirmed by a supplemental assay such as IgG/IgM ELISA, RT-PCR or HI (RAPHA SERO) test. This is an In vitro diagnostic test for professional use only

Class C

Brand: SECURE

Class B