IVD Department quantitative CK-MB testing
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·SD Biosensor, Inc.·Registered Oct 22, 2024- Analysis ID
- 2402948ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-201228-0015
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- SD Biosensor, Inc.
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- SD Biosensor, Inc.
- Authorized Representative
- CÔNG TY CỔ PHẦN Y TẾ ĐỨC MINH
- Intended Use
- 1. STANDARD™ F CK-MB Control: The STANDARD™ F CK-MB Control is designed to control the performance of the STANDARD™ F CK-MB FIA and STANDARD™ F Analyzer. It is recommended to perform at least two levels of the control material concentration test regularly at the laboratory. Quality control testing must be performed according to the specified requirements and standard procedures of each laboratory. 2. STANDARD™ F CK-MB FIA: The STANDARD™ F CK-MB FIA is a fluorescent immunoassay for the quantitative determination of the concentration of the total CK-MB isoform in serum or whole blood of humans on the STANDARD™ F Analyzer, manufactured by SD BIOSENSOR. This test is intended for in vitro diagnosis and is aimed at assisting in the screening and monitoring of myocardial infarction (MI).
- Registration Date
- Oct 22, 2024
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Access comprehensive regulatory information for IVD Department quantitative CK-MB testing 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 2402948ĐKLH/BYT-HTTB and manufactured by SD Biosensor, Inc.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN Y TẾ ĐỨC MINH.
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