Vietnam MOH registration 2403396ĐKLH/BYT-HTTB

Qualitative blood group control test materials for the ABO system, the Rh(D) system, the Kell system, and atypical antibodies

VN: Vật liệu kiểm soát xét nghiệm định tính nhóm máu hệ ABO, hệ Rh(D), hệ Kell, kháng thể bất thường
Vietnam flagVietnam·Risk Class TTBYT Loại D·ORTHO CONFIDENCE™ WB Simulated Whole Blood Quality Control Kit·Alba Bioscience Limited·Registered Nov 06, 2024
Registration details
Analysis ID
2403396ĐKLH/BYT-HTTB
Submission ID
19010986/ĐKLH-BYT-TB-CT
Product Type
ORTHO CONFIDENCE™ WB Simulated Whole Blood Quality Control Kit
Product Code
6842785
Company information
Manufacturer Country
UNITED KINGDOM
Product Owner
Alba Bioscience Limited
Technical details
Intended Use
The use of a control standard to ensure the reliability of the blood bank serum test drug and the automated/manual blood typing systems that use the precipitation coagulation technique.
Dates and status
Registration Date
Nov 06, 2024
About this record

Access comprehensive regulatory information for Qualitative blood group control test materials for the ABO system, the Rh(D) system, the Kell system, and atypical 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 2403396ĐKLH/BYT-HTTB and manufactured by Alba Bioscience Limited. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM.

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