Dengue IgG/IgM Ab Test
- UID
- MFG/IVD/2021/000062_12ee3a71825a27e1d5ffc0d5423f45e8_e62586db0cfa6e6c6ecf6ca362f71a25
- Device class
- Class B
- Brand name
- hCG
- License holder
- Mylab Discovery Solutions Pvt. Ltd. Lonavla
- Approving authority
- Pune Division
- Product information
- The Dengue IgG/IgM Ab Test is a solid-phase immunochromatographic assay for the rapid, qualitative, and differential detection of IgG and IgM antibodies to dengue virus in the human specimen. This test is for in-vitro professional diagnostic use and intended as an aid to early diagnosis of dengue infection in a patient with clinical symptoms of dengue infection. It provides only an initial screening test result. More specific alternative diagnosis methods should be performed to obtain the confirmation of dengue infection
Dengue IgG/IgM Ab Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000062_12ee3a71825a27e1d5ffc0d5423f45e8_e62586db0cfa6e6c6ecf6ca362f71a25. This device is marketed under the brand name hCG. The license holder is Mylab Discovery Solutions Pvt. Ltd. Lonavla, and it is classified as Device Class Class B. The approving authority is Pune Division.
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