Rapid Test for detection of IgM and IgG Antibodies to Dengue Virus Device - India CDSCO Medical Device Registration

Rapid Test for detection of IgM and IgG Antibodies to Dengue Virus Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000091_73de9738b608f935b53aa431bcfd72cb_4ed030d221e78c59cb377e40f2079639. This device is marketed under the brand name DENGUCHECK WB Device. The license holder is VIOLA DIAGNOSTIC SYSTEMS - A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED,, and it is classified as Device Class Class B. The approving authority is Uttarakhand.

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CDSCO Registered

Class Class B

Rapid Test for detection of IgM and IgG Antibodies to Dengue Virus Device

UID: MFG/IVD/2021/000091_73de9738b608f935b53aa431bcfd72cb_4ed030d221e78c59cb377e40f2079639

Brand Name

DENGUCHECK WB Device

License Holder

VIOLA DIAGNOSTIC SYSTEMS - A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED,

Device Class

Class B

Approving Authority

Uttarakhand

Product Information

Rapid Qualitative Sandwich Immunoassay for the detection of IgM and IgG Antibodies to dengue Virus in human serum, plasma and whole blood. The Test can be used for screening Dengue viral infection and as an aid for differential diagnosis of self limiting primary dengue infections and potentially fatal secondary Dengue infections in conjunction with other criteria