Dengue IgG/IgM Rapid Test - India CDSCO Medical Device Registration
Dengue IgG/IgM Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000081_1b7c799a223f84d606c111737f26e671_96caab84818e264c4e74964b131f08c4. This device is marketed under the brand name TRURAPID® RESIST CTX-M Rapid Test. The license holder is KILPEST INDIA LIMITED, and it is classified as Device Class Class B. The approving authority is Madhya Pradesh.
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Brand Name
TRURAPID® RESIST CTX-M Rapid Test
License Holder
KILPEST INDIA LIMITEDDevice Class
Approving Authority
Madhya Pradesh
Product Information
Dengue Antibody test reagent/kit is a medical device intended for the detection of Dengue Antibody in blood/body fluids. TRURAPID® Dengue IgG/IgM Test is an immune-chromatographic assay designed for the qualitative detection and differentiation of specific IgM and IgG antibodies to dengue virus in human whole blood, serum, or plasma. It is intended to be used as in-vitro diagnostic of dengue fever. The test can be used for the presumptive distinction between a primary and secondary dengue infection. The results obtained should not be the sole determinant for clinical decisions. Test should be performed by trained personnel who have received the required training for rapid test.
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