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Malaria Pf /Pan antigen rapid test kit - India CDSCO Medical Device Registration

Malaria Pf /Pan antigen rapid test kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000109_68b0e4b7d8e535ebf75f8f710a19ee0d_08aa8285c8b7d3118cf4732f2e1e8fa0. The license holder is Levram Lifesciences Private Limited, 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 Pf /Pan antigen rapid test kit
UID: MFG/IVD/2022/000109_68b0e4b7d8e535ebf75f8f710a19ee0d_08aa8285c8b7d3118cf4732f2e1e8fa0

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

This is a rapid, differential Qualitative Detection, Sandwich immunoassay utilizing whole blood for the detection of P. falciparum specific histidine rich protein-2 ##PLACEHOLDER_0## and P. Vivax, P. ovale and P. malariae specific pLDH. The test may also be used for the differentiation of P. falciparum and P. Vivax, P. ovale and P. malariae and for the follow-up of antimalarial therapy in whole blood samples

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