IVD Department quantitative CK-MB testing
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Theo theo phụ lục·Registered Dec 27, 2022- Analysis ID
- 2200184ĐKLH/BYT-TB-CT
- Submission ID
- 000.00.04.G18-210914-0016
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Theo theo phụ lục
- Manufacturer Country
- Theo theo phụ lục
- Intended Use
- Alinity c CK-MB Test is used to measure the kinetics of the CK-MB and CK-BB isoenzymes of creatine kinase in serum or plasma on the Alinity c analyzer. Alinity c CK-MB Calibrator is used to calibrate the CK-MB test on the Alinity c analyzer. Alinity c CK-MB Control is used only to assess the performance of the Alinity c CK-MB test on the Alinity c analyzer.
- Registration Date
- Dec 27, 2022
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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 2200184ĐKLH/BYT-TB-CT and manufactured by Theo theo phụ lục.
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