Vietnam MOH registration 2403239ĐKLH/BYT-HTTB

IVD Department Qualitative Antibody Test for HTLV-I and HTLV-II

VN: Bộ IVD xét nghiệm định tính kháng thể kháng HTLV-I và HTLV-II

Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Abbott GmbH·Registered Nov 02, 2024

Registration details

Analysis ID: 2403239ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-231201-0014
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: The ARCHITECT rHTLV-I/II calibrator is used to calibrate the ARCHITECT iSystem when performing qualitative detection of HTLV-I and HTLV-II antibodies in human serum and plasma. Refer to the ARCHITECT rHTLV-I/II Assay User Manual and the ARCHITECT System Operations Manual for more information. The ARCHITECT rHTLV-I/II control material is used to assess the accuracy of the test and to detect systematic analytical deviation of the ARCHITECT iSystem when performing qualitative detection of HTLV-I and HTLV-II antibodies in human serum and plasma. Refer to the ARCHITECT rHTLV-I/II Assay User Manual and the ARCHITECT System Operations Manual for more information. The ARCHITECT rHTLV-I/II is a fluorescent bead-based immunoassay (CMIA) for qualitative detection of HTLV-I and HTLV-II antibodies in human serum and plasma, including samples collected from patients who have no pulse (cardiac arrest). The ARCHITECT rHTLV-I/II test is used to support the diagnosis of HTLV-I and HTLV-II infections, and is used as a screening test to prevent the transmission of HTLV-I and HTLV-II infected blood, blood components, cells, tissues, and organs.

Dates and status

Registration Date: Nov 02, 2024

About this record

Access comprehensive regulatory information for IVD Department Qualitative Antibody Test for HTLV-I and HTLV-II 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 2403239ĐKLH/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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