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
- Device class
- Class C
- Brand name
- Crystal Dengue NS1
- License holder
- ARKRAY HEALTHCARE PVT. LTD.
- 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
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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