Vietnam MOH registration 2301812ĐKLH/BYT-HTTB

IVD Department quantitative test for the surface antigen of hepatitis B virus (HBsAg)

VN: Bộ IVD xét nghiệm định lượng kháng nguyên bề mặt virus viêm gan B (HBsAg)

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Theo theo phụ lục·Registered Dec 30, 2023

Registration details

Analysis ID: 2301812ĐKLH/BYT-HTTB
Submission ID: 17001244/ĐKLH-BYT-TB-CT
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Theo theo phụ lục
Manufacturer Country: Theo theo phụ lục

Technical details

Intended Use: Alinity i HBsAg Calibrators are used to calibrate the Alinity i analyzer when performing quantitative testing of the hepatitis B surface antigen (HBsAg) in human serum and plasma. Alinity i HBsAg Controls are used to monitor the calibration of the Alinity i analyzer when performing quantitative testing of the hepatitis B surface antigen (HBsAg) in human serum and plasma. The Alinity i HBsAg test is a chemiluminescent microparticle immunoassay (CMIA) used to quantitate the hepatitis B surface antigen (HBsAg) in human serum and plasma samples on the Alinity i analyzer.

Dates and status

Registration Date: Dec 30, 2023

About this record

Access comprehensive regulatory information for IVD Department quantitative test for the surface antigen of hepatitis B virus (HBsAg) in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2301812ĐKLH/BYT-HTTB and manufactured by Theo theo phụ lục.

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