Malaria Pf Rapid Malaria Ag Detection test (Detection of Pf Antigen) - India CDSCO Medical Device Registration
Malaria Pf Rapid Malaria Ag Detection test (Detection of Pf Antigen) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000020_9dcf194f5bae11cd8f2bdce7b87691aa_81f77db3f444ce6448c7f67970006eda. 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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Brand Name
EzDx
License Holder
ADVY CHEMICAL PVT. LTD.Device Class
Approving Authority
Central Drug Standards Control Organization, West Zone
Product Information
Malaria Pf test kit is an in-vitro diagnostic Immunochromatographic assay for the qualitative detection of malaria infection caused by Plasmodium falciparum parasites in human. It detects HRP-II (EzDx) antigen of Plasmodium falciparum in whole blood specimens. It does not assess parasite densities. The test must be performed by trained professional user and not by lay users
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