Vietnam MOH registration 2403569ĐKLH/BYT-HTTB

Drug Test for Quantitative Analysis of Catalytic Activity of the Creatine Kinase MB Isoenzyme

VN: Thuốc thử xét nghiệm định lượng hoạt tính xúc tác của tiểu đơn vị creatine kinase MB

Vietnam·Risk Class TBYT Loại C·CKMB·Roche Diagnostics GmbH·Registered Nov 14, 2024

Registration details

Analysis ID: 2403569ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-240901-0002
Product Type: CKMB
Product Code: 08057486190

Company information

Manufacturer: Roche Diagnostics GmbH
Manufacturer Country: GERMANY
Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

Technical details

Intended Use: In vitro testing used to quantify the catalytic activity of the creatine kinaseMB (CK‑MB) monomer in human serum and plasma on various cobas systems.

Dates and status

Registration Date: Nov 14, 2024

About this record

Access comprehensive regulatory information for Drug Test for Quantitative Analysis of Catalytic Activity of the Creatine Kinase MB Isoenzyme in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại C medical device is registered under number 2403569ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics GmbH. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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