IVD Department Qualitative IgM Antibody to HBcAg Test
Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Theo theo phụ lục·Registered Sep 26, 2023- Analysis ID
- 2300856ĐKLH/BYT-HTTB
- Submission ID
- 18007144/ĐKLH-BYT-TB-CT
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Theo theo phụ lục
- Manufacturer Country
- Theo theo phụ lục
- Intended Use
- Architect Anti-HBc IgM Calibrators are used to calibrate the Architect i analysis system when performing qualitative detection of anti-HBc IgM antibodies against the core antigen of the hepatitis B virus (anti-HBc IgM) in human serum and plasma. Architect Anti-HBc IgM Controls are used to monitor the calibration of the Architect i analysis system when performing qualitative detection of anti-HBc IgM antibodies against the core antigen of the hepatitis B virus (anti-HBc IgM) in human serum and plasma. ARCHITECT Anti-HBc IgM is a fluorescent bead-based immunoassay (CMIA) for qualitative detection of anti-HBc IgM antibodies against the core antigen of the hepatitis B virus (HBc IgM) in human serum or plasma and is used to aid in the diagnosis of acute or newly acquired hepatitis B.
- Registration Date
- Sep 26, 2023
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Access comprehensive regulatory information for IVD Department Qualitative IgM Antibody to HBcAg Test in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2300856ĐKLH/BYT-HTTB and manufactured by Theo theo phụ lục.
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