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Dengue Combo Rapid Dengue NS1 Antigen & Dengue IgM/IgG Antibody Detection test - India CDSCO Medical Device Registration

Dengue Combo Rapid Dengue NS1 Antigen & Dengue IgM/IgG Antibody Detection test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000020_762160ec1a351f6125a8f8719506fea6_b060c1f5fea743b9e9c5397b425bb67d. This device is marketed under the brand name EzDx. The license holder is ADVY CHEMICAL PVT. LTD., and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.

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CDSCO Registered
Class Class C
Dengue Combo Rapid Dengue NS1 Antigen & Dengue IgM/IgG Antibody Detection test
UID: MFG/IVD/2021/000020_762160ec1a351f6125a8f8719506fea6_b060c1f5fea743b9e9c5397b425bb67d

Brand Name

EzDx

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

Dengue Combo (EzDx) is a rapid qualitative immune chromatographic test for the detection of Dengue NS1 Antigen & differential detection of IgM & IgG antibodies to dengue virus in human Serum/Plasma/Whole blood. This test is for In Vitro diagnostic use only and is intended as an aid in the earlier diagnosis of dengue infection & presumptive diagnosis between primary and secondary dengue infection

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