CK-MB Quantitative Testing Drug - Vietnam Registration 2402897ĐKLH/BYT-HTTB
Access comprehensive regulatory information for CK-MB Quantitative Testing Drug 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 2402897ĐKLH/BYT-HTTB. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN LIFE TECHNOLOGIES HOLDINGS PTE. LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH.
This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Rayto Life and Analytical Sciences Co., Ltd, DiaSys Diagnostic Systems GmbH, and 2 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.
Device Details
Registration Details
2402897ĐKLH/BYT-HTTB
000.00.04.G18-240122-0005
Theo theo phụ lục
Theo phụ lục
Technical Details
To be used in in vitro diagnosis for the determination of the quantitative activity of CK-MB (the B isoenzyme of creatine kinase, ATP: Creatine N-Phosphotransferase (CK), EC 2,7.3.2) in human serum and plasma by the automated procedures of the Thermo Scientific™ Indiko™ and Konelab™ analyzers. The CK-MB test is indicated for use in combination with clinical evaluation to support the diagnosis of myocardial injury and muscle bone damage in patients.
Dates and Status
Oct 22, 2024