Rapid Test for P. falciparum and Pan Malarial Species-Device - India CDSCO Medical Device Registration

Rapid Test for P. falciparum and Pan Malarial Species-Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2019/000025_c935f52841589ce8f68f693bc869858d_fd40b5ec0ebeb3ac1423b14a8f88b232. 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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CDSCO Registered

Class Class C

Rapid Test for P. falciparum and Pan Malarial Species-Device

UID: MFG/IVD/2019/000025_c935f52841589ce8f68f693bc869858d_fd40b5ec0ebeb3ac1423b14a8f88b232

Brand Name

Crystal Dengue NS1

License Holder

ARKRAY HEALTHCARE PVT. LTD.

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

The ParaHIT Total+ Rapid Test for P. falciparum and Pan Malarial Species provides a simple, rapid and in vitro qualitative screening test for detection of all four species of Plasmodium genus that cause Malaria in humans, viz. Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale and Plasmodium malariae. The test is intended for use with whole blood and does not require any additional instrument. The assay is intended for use by Health Care Workers/Laboratory Professionals, for an initial screening of malaria in symptomatic patients

Class C

Immunochromatographic rapid visual test for detection of Dengue NS1 Antigen and Differential Anti-Dengue IgG and IgM antibodies in Human Serum, Plasma or Whole Blood – Device

Brand: Crystal Dengue NS1

ARKRAY HEALTHCARE PVT. LTD.

Class C

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