Vietnam MOH registration 2403572ĐKLH/BYT-HTTB

Qualitative blood group antigen test card for ABO and Rh(D) and detection of abnormal antibodies

VN: Thẻ xét nghiệm định tính kháng nguyên nhóm máu hệ ABO và Rh(D) và phát hiện kháng thể bất thường

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

Registration details

Analysis ID: 2403572ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230809-0007
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Haemokinesis Limited
Manufacturer Country: Theo theo phụ lục
Product Owner: Haemokinesis Limited
Authorized Representative: CÔNG TY CỔ PHẦN THIẾT BỊ Y TẾ VIMEC

Technical details

Intended Use: The card for determining blood type is used to test the combination of ABO and Rh(D) blood group antigens. The STARGEL10 Crossmatch card allows for the confirmation of the ABO/Rh(D) blood type of both the recipient and the donor or just the recipient, along with the detection of clinically significant donor-specific antibodies using the recipient's red blood cells and plasma in the IAT and autoIAT tests. The test reagents used by trained personnel.

Dates and status

Registration Date: Nov 14, 2024

About this record

Access comprehensive regulatory information for Qualitative blood group antigen test card for ABO and Rh(D) and detection of abnormal antibodies 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 2403572ĐKLH/BYT-HTTB and manufactured by Haemokinesis Limited. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ Y TẾ VIMEC.

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