Rapid Test for P. falciparum Malaria - Dipstick - India CDSCO Medical Device Registration
Rapid Test for P. falciparum Malaria - Dipstick is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2019/000025_fbba546823a1835a1b2a2aef88e71170_ed9fbdde54bdcbda4e35a31cf90a34c2. This device is marketed under the brand name Crystal Dengue NS1. The license holder is ARKRAY HEALTHCARE PVT. LTD., and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
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Brand Name
Crystal Dengue NS1
License Holder
ARKRAY HEALTHCARE PVT. LTD.Device Class
Approving Authority
Central Drug Standards Control Organization, Ahmedabad
Product Information
ParaHIT f Ver. 1.0 - Rapid Test for P. falciparum Malaria provides a simple, rapid and an in vitro qualitative screening test for the detection of Plasmodium falciparum specific HRP-II (Crystal Dengue NS1) in human blood. It does not require additional instrument. The assay is intended for use by Health Care Workers / Laboratory Professionals, only for an initial screening. The assay is to be used in the diagnosis of malaria in symptomatic patients. This test kit is standardized to withstand tropical conditions
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