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Hepatitis A Virus IgM Rapid Test - India CDSCO Medical Device Registration

Hepatitis A Virus IgM Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000041_805a62607c96b0c90336101e18a5d23a_d8e11860af66423d604563d0e4146078. This device is marketed under the brand name Feces. The license holder is NULIFE, and it is classified as Device Class Class B. The approving authority is Uttar Pradesh.

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CDSCO Registered
Class Class B
Hepatitis A Virus IgM Rapid Test
UID: MFG/MD/2018/000041_805a62607c96b0c90336101e18a5d23a_d8e11860af66423d604563d0e4146078

Brand Name

Feces

License Holder

NULIFE

Device Class

Class B

Approving Authority

Uttar Pradesh

Product Information

The reagent is used to detect the hepatitis A virus IgM Antibody in serum/plasma/whole blood qualitatively. Hepatitis A virus (Feces) is a kind of RNA virus, which belongs to the family of Picornavirus. HAV showed a spherical particles shape with 27 nm in diameter, icosahedral symmetry consisted of 32 shell particles, containing linear single-strand RNA. Hepatitis A is a kind of intestinal infectious disease caused by hepatitis A virus (Feces) with a worldwide distribution. Children and adolescents are most likely to be infected, and the peak incidence is in winter and spring. Hepatitis A is the most common type of acute viral hepatitis, mainly spread by fecal-oral route. The incubation period of hepatitis A virus is 15 to 45 days, HAV-IgM antibody can be detected in serum a short time later after infected, continue to rise very rapidly, peaking in about 2 weeks, decreasing gradually, disappear in 8 weeks. While HAV-IgG antibody appear later than IgM and will persistent for a long time. Detection of HAV- IgM antibody can diagnose HAV infection in early stage for its simple, fast, and high specificity. Both the immunological detection and virus nucleic acid detection can be used as the basis for laboratory diagnosis of hepatitis A virus

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