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

Malaria Pan/Pf Rapid Test Detection Kit (Detection of Pan and Pf Antigen) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000020_baf96672b4f06a7301d67bb976601e44_2db366040873c92643c43be57ab9ebe1. 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 Pan/Pf Rapid Test Detection Kit (Detection of Pan and Pf Antigen)
UID: MFG/IVD/2021/000020_baf96672b4f06a7301d67bb976601e44_2db366040873c92643c43be57ab9ebe1

Brand Name

EzDx

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

Malaria Pan/Pf 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 other Plasmodium species (EzDx) (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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