Dengue IgG/IgM card Test - India CDSCO Medical Device Registration

Dengue IgG/IgM card Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID KTK/28/298/98_23f571573fa62b92e447b5aca2ceb3d3_e4c933c052591b88e5a6353c623e31c9. This device is marketed under the brand name RF. The license holder is Bhat Bio-Tech India Private Limited, and it is classified as Device Class Class B. The approving authority is Karnataka.

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CDSCO Registered

Class Class B

Dengue IgG/IgM card Test

UID: KTK/28/298/98_23f571573fa62b92e447b5aca2ceb3d3_e4c933c052591b88e5a6353c623e31c9

Brand Name

License Holder

Bhat Bio-Tech India Private Limited

Device Class

Class B

Approving Authority

Karnataka

Product Information

Dengue IgG/IgM rapid card test is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to dengue virus in human serum or plasma or whole blood. This test is intended for Professional use as aid in the presumptive diagnosis between primary and secondary dengue infection