Dengue NS1-Dengue IgG/IgM Combo Rapid Test - India CDSCO Medical Device Registration

Dengue NS1-Dengue IgG/IgM Combo Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2018/000034_7c5d550920192a38d1ab0e4a24de2a1d_a15719a7dbc6a2a0a2b67fa87ae5c2a3. This device is marketed under the brand name Colloidal Gold. The license holder is APEX DIAGNOSTICS, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Dengue NS1-Dengue IgG/IgM Combo Rapid Test

UID: IMP/IVD/2018/000034_7c5d550920192a38d1ab0e4a24de2a1d_a15719a7dbc6a2a0a2b67fa87ae5c2a3

Brand Name

Colloidal Gold

License Holder

APEX DIAGNOSTICS

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Dengue NS1+IgM/IgG Combo Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of dengue virus NS1 antigen and IgM/IgG antibodies to dengue virus in whole Blood, serum or plasma to aid in the diagnosis of dengue viral infection