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Rapid Test for detection of Dengue NS1 Antigen and IgG/IgM Antibodies (Dengucheck Combo ) - India CDSCO Medical Device Registration

Rapid Test for detection of Dengue NS1 Antigen and IgG/IgM Antibodies (Dengucheck Combo ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000130_bde8349753405f49a03836f9baaa0cdc_ad378bbd236ca96c6f3c9b44512d76a6. This device is marketed under the brand name Paracheck Pf Device. The license holder is VIOLA DIAGNOSTIC SYSTEMS - A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED,, and it is classified as Device Class Class C. The approving authority is CDSCO -North Zone, Ghaziabad.

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CDSCO Registered
Class Class C
Rapid Test for detection of Dengue NS1 Antigen and IgG/IgM Antibodies (Dengucheck Combo )
UID: MFG/IVD/2020/000130_bde8349753405f49a03836f9baaa0cdc_ad378bbd236ca96c6f3c9b44512d76a6

Brand Name

Paracheck Pf Device

Device Class

Class C

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

Dengucheck Combo is a rapid, qualitative immunochromatographic test for the detection of Dengue NS1(Paracheck Pf Device) antigen and differential detection of IgG & IgM antibodies to Dengue virus in human serum or plasma. The test system can be used as a screening test for Dengue viral infection and as an aid for differential diagnosis of the self limiting primary Dengue infections and the potentially fatal secondary Dengue infections in conjunction with other criteria

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