Vietnam MOH registration 2403252ĐKLH/BYT-HTTB

IVD Department, quantitative DNA testing of EBV

VN: Bộ IVD xét nghiệm định lượng DNA của EBV

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Abbott Molecular Inc.·Registered Nov 02, 2024

Registration details

Analysis ID: 2403252ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-231205-0003
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

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

Technical details

Intended Use: Alinity m EBV AMP Kit: Alinity m EBV is an in vitro PCR test used with the Alinity m automated system to quantify the DNA of the Epstein-Barr virus (EBV) in human EDTA blood. Alinity m EBV is indicated for use as a diagnostic and management tool for EBV in transplant patients and other immunocompromised patients. In patients being monitored for EBV, the concentrations of DNA in the sample series can indicate the need for a change in therapy and the evaluation of viral response. The results of the Alinity m EBV test must be interpreted in conjunction with all clinical findings and relevant test data. The Alinity m EBV test is not indicated for use in screening for EBV in blood, blood products, or tissues or organs from human donors. Alinity m EBV CTRL Kit: The Alinity m EBV control samples are used to determine the validity of the Alinity m EBV test on the Alinity m automated system. These control samples are intended for use with the Alinity m EBV test; refer to the test's user manual for additional information. Alinity m EBV CAL Kit: The Alinity m EBV calibration samples are used to calibrate the Alinity m EBV test on the Alinity m automated system when quantifying the DNA of EBV. These calibration samples are intended for use with the Alinity m EBV test; refer to the test's user manual for additional information.

Dates and status

Registration Date: Nov 02, 2024

About this record

Access comprehensive regulatory information for IVD Department, quantitative DNA testing of EBV 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 2403252ĐKLH/BYT-HTTB and manufactured by Abbott Molecular Inc.. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI.

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