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

Dengue IgG/IgM Combo Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000307_f6fc1af74265c881e668f15470b0c405_741172aafd926f96d5626dfe56eddbe3. This device is marketed under the brand name RecombiLISA. The license holder is Athenese-Dx Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

CDSCO Registered

Class Class B

Dengue IgG/IgM Combo Rapid Test

UID: IMP/IVD/2019/000307_f6fc1af74265c881e668f15470b0c405_741172aafd926f96d5626dfe56eddbe3

Brand Name

RecombiLISA

License Holder

Athenese-Dx Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

"The Dengue IgG/IgM Combo Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of anti–dengue virus (RecombiLISA) IgG and IgM in human serum, plasma or whole blood. It is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of infection with dengue viruses."

Class B

Leishmania Ab Rapid Test

Brand: RecombiLISA

Athenese-Dx Private Limited

Class B

Brand: TRUSTline

Class D