Vietnam MOH registration 2400618ĐKLH/BYT-HTTB

Standardized Reagent for Prothrombin Time Determination

VN: Chất hiệu chuẩn xét nghiệm xác định thời gian Prothrombin

Vietnam·Risk Class TTBYT Loại C·BE Cal Set/ Calibration Plasma PT·Biolabo SAS·Registered May 10, 2024

Registration details

Analysis ID: 2400618ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-210621-0017
Product Type: BE Cal Set/ Calibration Plasma PT
Product Code: 775200

Company information

Manufacturer: Biolabo SAS
Manufacturer Country: FRANCE
Product Owner: Biolabo SAS
Authorized Representative: CÔNG TY TNHH THIẾT BỊ Y TẾ PHƯƠNG ĐÔNG

Technical details

Intended Use: BE Cal Set/ Calibration Plasma PT is designated for professional use in the laboratory (manual or automated method). Plasma is extracted to calibrate in the process of determining Prothrombin Time. Each concentration has a defined value for PT (%) and INR (International Normalized Ratio).

Dates and status

Registration Date: May 10, 2024

About this record

Access comprehensive regulatory information for Standardized Reagent for Prothrombin Time Determination 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 2400618ĐKLH/BYT-HTTB and manufactured by Biolabo SAS. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ PHƯƠNG ĐÔNG.

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