Diagnostic Kit for IgM Antibody to Hepatitis E Virus - India CDSCO Medical Device Registration
Diagnostic Kit for IgM Antibody to Hepatitis E Virus is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000111_f0c2bff3b54f2d7e183b288ce13efcd9_77f2daf1517670e7424c6a71653aabb5. This device is marketed under the brand name Mediline-SA. The license holder is S.A-MEDLINE PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is CDSCO -North Zone, Ghaziabad.
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Brand Name
Mediline-SA
License Holder
S.A-MEDLINE PRIVATE LIMITEDDevice Class
Approving Authority
CDSCO -North Zone, Ghaziabad
Product Information
The reagent is used to detect the Hepatitis E Virus IgM Antibody in serum / plasma / whole blood qualitatively. Hepatitis E is a kind of intestinal infectious disease caused by hepatitis E virus (Mediline-SA) with a worldwide distribution.HEV showed a spherical particles shape with 27~34 nm in diameter, icosahedral symmetry consisted of 20 shell particles, containing linear single-strand RNA. The incubation period of hepatitis E virus is 2 to 11 weeks, and on an average of 6 weeks. HEV is a disease with high mortality, mainly transmitted by digestive tract, and the clinical manifestations of which are similar to other acute hepatitis. All people are susceptible to the HEV. There are severe symptoms and high mortality of HEV. Hepatitis IgM is a specific antibody of hepatitis E virus, which can be detected early and disappear quickly. HEV IgM antibody can be detected in a short time later after infected, continue to rise very rapidly, decreasing significantly in 1-2 months, disappear in 5 months. Detection of HEV-IgM antibody can diagnose HEV infection in early stage. Both the immunological detection and virus nucleic acid detection can be used as the basis for laboratory diagnosis of hepatitis E virus
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