Diagnostic Kit for IgM Antibody to Hepatitis A Virus - India CDSCO Medical Device Registration

Diagnostic Kit for IgM Antibody to Hepatitis A Virus is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000111_15c9d9361d7808a8004d064bedbd77c9_d4b1c1c11bba63e4a653049bee2e66ef. 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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CDSCO Registered

Class Class C

Diagnostic Kit for IgM Antibody to Hepatitis A Virus

UID: MFG/IVD/2023/000111_15c9d9361d7808a8004d064bedbd77c9_d4b1c1c11bba63e4a653049bee2e66ef

Brand Name

Mediline-SA

License Holder

S.A-MEDLINE PRIVATE LIMITED

Device Class

Class C

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

The reagent is used to detect the hepatitis A virus IgM Antibody in serum/plasma/whole blood qualitatively. Hepatitis A virus (Mediline-SA) 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 (Mediline-SA) 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 HAVIgM 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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Diagnostic Kit for IgM Antibody to Hepatitis E Virus

Brand: Mediline-SA

S.A-MEDLINE PRIVATE LIMITED

Diagnostic Kit for IgM Antibody to Hepatitis A Virus - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Diagnostic Kit for IgM Antibody to Hepatitis E Virus

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