Vietnam MOH registration 230002387/PCBB-HCM

IVD Enzymes Cluster: CK, CK-MB

VN: Cụm IVD Enzymes: CK, CK-MB

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Theo theo phụ lục·Registered Nov 01, 2023

Registration details

Analysis ID: 230002387/PCBB-HCM
Submission ID: 000.00.19.H29-231027-0019
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Theo theo phụ lục
Manufacturer Country: Theo theo phụ lục

Technical details

Intended Use: The CK-MB quantitative test reagent is a tool used in the laboratory to quantify CK-MB in human serum and plasma. The CK-MB quantitative test calibration standard is used to calibrate the quantitative test for CK-MB in human serum and plasma. The CK-MB quantitative test control material is used to control the quantitative test for CK-MB in human serum and plasma. The CK quantitative test reagent is used to determine the concentration of Creatine in serum and plasma. The CK quantitative test control material is used to control the accuracy

Dates and status

Registration Date: Nov 01, 2023

About this record

Access comprehensive regulatory information for IVD Enzymes Cluster: CK, CK-MB in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 230002387/PCBB-HCM and manufactured by Theo theo phụ lục.

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