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

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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CDSCO Registered

Class Class B

Dengue IgG/IgM Ab Test

UID: MFG/IVD/2021/000062_12ee3a71825a27e1d5ffc0d5423f45e8_e62586db0cfa6e6c6ecf6ca362f71a25

Brand Name

hCG

License Holder

Mylab Discovery Solutions Pvt. Ltd. Lonavla

Device Class

Class B

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

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Dengue IgG/IgM Ab Test

Brand: SickleCatch™

Mylab Discovery Solutions Pvt. Ltd.

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

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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