Vietnam MOH registration 2402547ĐKLH/BYT-HTTB

CK-MB Quantitative Testing Control Reagent Kit

VN: Bộ thuốc thử, chất hiệu chuẩn xét nghiệm định lượng CK-MB

Vietnam·Risk Class TTBYT Loại C·IMMULITE/ IMMULITE 1000 CK-MB (Name on Label: IMMULITE/IMMULITE Systems 1000 CK-MB)·Siemens Healthcare Diagnostics Products Limited·Registered Aug 30, 2024

Registration details

Analysis ID: 2402547ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-210719-0012
Product Type: IMMULITE/ IMMULITE 1000 CK-MB (Name on Label: IMMULITE/IMMULITE Systems 1000 CK-MB)
Product Code: 10381016/ LKMB1

Company information

Manufacturer: Siemens Healthcare Diagnostics Products Limited
Manufacturer Country: UNITED KINGDOM
Product Owner: Siemens Healthineers
Authorized Representative: CÔNG TY TNHH SIEMENS HEALTHCARE

Technical details

Intended Use: To be used in in vitro diagnostic with the IMMULITE and IMMULITE 1000 Analyzers - to measure the quantitative isoenzyme MB of creatine kinase (CK-MB) in heparin-anticoagulated blood or serum, as a supportive measure in the management of patients and in the risk assessment of myocardial infarction.

Dates and status

Registration Date: Aug 30, 2024

About this record

Access comprehensive regulatory information for CK-MB Quantitative Testing Control Reagent 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 2402547ĐKLH/BYT-HTTB and manufactured by Siemens Healthcare Diagnostics Products Limited. The authorized representative in Vietnam is CÔNG TY TNHH SIEMENS HEALTHCARE.

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