Vietnam MOH registration 2400654ĐKLH/BYT-HTTB

Creatine Kinase MB Quantitative Standardized Reference Material

VN: Thuốc thử, chất hiệu chuẩn định lượng Creatine Kinase MB

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Ortho-Clinical Diagnostics Inc.·Registered May 10, 2024

Registration details

Analysis ID: 2400654ĐKLH/BYT-HTTB
Submission ID: 19010949/ĐKLH-BYT-TB-CT
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Ortho-Clinical Diagnostics Inc.
Manufacturer Country: Theo theo phụ lục
Product Owner: Ortho-Clinical Diagnostics Inc.
Authorized Representative: CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM

Technical details

Intended Use: (1) VITROS Chemistry Products CKMB Slides are used in in vitro diagnosis to quantify the activity of creatine kinase MB (CK-MB) in serum using the VITROS 250/350/5,1 FS, 4600, XT 3400 and VITROS 5600/XT 7600 biochemical assay systems. (2) VITROS Chemistry Products Calibrator Kit 6 is used in in vitro diagnosis to calibrate the VITROS 250/350/5,1 FS/4600/XT 3400 and VITROS 5600/XT 7600 biochemical assay systems when quantifying Cholinesterase (CHE) and Creatine Kinase MB (CKMB).

Dates and status

Registration Date: May 10, 2024

About this record

Access comprehensive regulatory information for Creatine Kinase MB Quantitative Standardized Reference Material 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 2400654ĐKLH/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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