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 - India CDSCO Medical Device Registration

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 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2019/000025_4d5da9b291dbee9e55b54d554aea015e_7f0ef76713c64751d9360d783e74bb8b. 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

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

UID: MFG/IVD/2019/000025_4d5da9b291dbee9e55b54d554aea015e_7f0ef76713c64751d9360d783e74bb8b

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

Crystal® Dengue Duo is an in vitro rapid qualitative screening test for detection of Dengue NS1 antigen and differential IgG.IgM antibodies to dengue virus in human serum, plasma or whole blood. This test is intended for use by skilled Health Care Workers / Laboratory Professionals to aid in the presumptive diagnosis dengue infection and so, results should be confirmed with alternative assays such as isolation of virus, antigen detection in fixed tissues, RT-PCR and serological test like hemagglutination-inhibition test

Class C

Brain Thromboplastin with Calcium Reagent for Prothrombin Time

Brand: Crystal Dengue NS1

ARKRAY HEALTHCARE PVT. LTD.

Class C

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