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Malaria Pv/Pf Rapid Malaria Ag Detection Test (Detection of Pv and Pf Antigen) - India CDSCO Medical Device Registration

Malaria Pv/Pf Rapid Malaria Ag Detection Test (Detection of Pv and Pf Antigen) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000020_52798df9dab2a3f1bcf341892bd347e4_91bdae1ea3efb1cecfad1516cfa9aed3. 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
Malaria Pv/Pf Rapid Malaria Ag Detection Test (Detection of Pv and Pf Antigen)
UID: MFG/IVD/2021/000020_52798df9dab2a3f1bcf341892bd347e4_91bdae1ea3efb1cecfad1516cfa9aed3

Brand Name

EzDx

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

Malaria Pv/Pf Test is a rapid in-vitro immuno-chromatographic immunoassay for the qualitative detection of malaria infection in human blood sample indicating differential diagnosis between P. falciparum, HRP-II (EzDx) and Plasmodium vivax species (EzDx). The test is intended for primary screening of malaria infection in symptomatic patients of all age groups. The test is intended for professional use and must be used by a trained personnel

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