Vietnam MOH registration 2403574ĐKLH/BYT-HTTB

Quantitative Test of CD3+/CD4+ Cells

VN: Thanh thử xét nghiệm định lượng tế bào CD3+/CD4+

Vietnam·Risk Class TTBYT Loại C·Pima™ CD4·Abbott Rapid Diagnostics Jena GmbH·Registered Nov 14, 2024

Registration details

Analysis ID: 2403574ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-240705-0007
Product Type: Pima™ CD4
Product Code: Theo phụ lục

Company information

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

Technical details

Intended Use: Pima CD4 is an automated blood immunology test based on imaging, used to quickly count the amount of CD3+/CD4+ T cells in the blood (helper T-cells) in the capillary or venous blood. Pima CD4 determines the absolute number of CD3+/CD4+ cells and is used for continuous monitoring of the absolute number of CD4 lymphocytes in patients diagnosed with immunodeficiency. The CD4 Pima test is used for diagnostic purposes in the blood.

Dates and status

Registration Date: Nov 14, 2024

About this record

Access comprehensive regulatory information for Quantitative Test of CD3+/CD4+ Cells 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 2403574ĐKLH/BYT-HTTB and manufactured by Abbott Rapid Diagnostics Jena GmbH. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI.

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