Vietnam MOH registration 2402231ĐKLH/BYT-HTTB

ABO Blood Group Test Reagent

VN: Thuốc thử xét nghiệm định nhóm máu ABO

Vietnam·Risk Class TTBYT Loại D·Affirmagen 4·Ortho-Clinical Diagnostics, Inc.·Registered Aug 27, 2024

Registration details

Analysis ID: 2402231ĐKLH/BYT-HTTB
Submission ID: 18006804/ĐKLH-BYT-TB-CT
Product Type: Affirmagen 4
Product Code: 707910

Company information

Manufacturer: Ortho-Clinical Diagnostics, Inc.
Manufacturer Country: UNITED STATES
Product Owner: Ortho-Clinical Diagnostics
Authorized Representative: CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM

Technical details

Intended Use: Used to detect ABO blood group antibodies in human serum/plasma to confirm the direct ABO blood typing (on red blood cells) on the Ortho BioVue System.

Dates and status

Registration Date: Aug 27, 2024

About this record

Access comprehensive regulatory information for ABO Blood Group Test Reagent 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 2402231ĐKLH/BYT-HTTB and manufactured by Ortho-Clinical Diagnostics, Inc.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM.

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