Vietnam MOH registration 2401180ĐKLH/BYT-HTTB

Qualitative Antigen M Test Kit

VN: Thuốc thử xét nghiệm định tính kháng nguyên M

Vietnam·Risk Class TTBYT Loại C·ORTHO™SeraAnti–M·Alba Bioscience Limited·Registered Jul 22, 2024

Registration details

Analysis ID: 2401180ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230921-0010
Product Type: ORTHO™SeraAnti–M
Product Code: 6904494

Company information

Manufacturer: Alba Bioscience Limited
Manufacturer Country: UNITED KINGDOM
Product Owner: Alba Bioscience Limited
Authorized Representative: CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM

Technical details

Intended Use: Used in in vitro qualitative testing to detect the presence of M-positive red blood cells in humans by direct agglutination test.

Dates and status

Registration Date: Jul 22, 2024

About this record

Access comprehensive regulatory information for Qualitative Antigen M Test Kit 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 2401180ĐKLH/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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