Vietnam MOH registration 2403602ĐKLH/BYT-HTTB

IVD Quantitative HBeAg Test Kit

VN: Bộ IVD xét nghiệm định lượng HBeAg

Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Abbott GmbH·Registered Nov 14, 2024

Registration details

Analysis ID: 2403602ĐKLH/BYT-HTTB
Submission ID: 18006933/ĐKLH-BYT-TB-CT
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Abbott GmbH
Manufacturer Country: Theo theo phụ lục
Product Owner: Abbott GmbH
Authorized Representative: VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI

Technical details

Intended Use: ARCHITECT HBeAg Quantitative Calibrators are used to calibrate the ARCHITECT iSystem and are intended for use only with the ARCHITECT HBeAg Test Kit. The ARCHITECT HBeAg test, combined with the ARCHITECT HBeAg Quantitative Calibrators, is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of hepatitis B e antigen (HBeAg) in human serum and plasma and for the monitoring of patients infected with the hepatitis B virus. ARCHITECT HBeAg Quantitative Controls are used to assess the accuracy of the test and to detect systematic analytical errors in the ARCHITECT iSystem when performing quantitative determinations of hepatitis B e antigen (HBeAg) in human serum and plasma. Refer to the ARCHITECT HBeAg Quantitative Calibrators User Guide (7P24-01) and the ARCHITECT System Operations Manual for additional information. ARCHITECT HBeAg is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B e antigen (HBeAg) in human serum and plasma. The test is used to support the diagnosis and monitoring of hepatitis B infection. The ARCHITECT HBeAg test can also be used to quantify HBeAg. Refer to the ARCHITECT HBeAg Quantitative Calibrators User Guide (7P24-01) for instructions and additional information.

Dates and status

Registration Date: Nov 14, 2024

About this record

Access comprehensive regulatory information for IVD Quantitative HBeAg Test Kit 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 2403602ĐKLH/BYT-HTTB and manufactured by Abbott GmbH. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI.

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