IVD Department quantitative Ethanol testing - Vietnam Registration 240000044/PCBB-BYT
Access comprehensive regulatory information for IVD Department quantitative Ethanol testing in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240000044/PCBB-BYT and manufactured by Ortho-Clinical Diagnostics, Inc.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM.
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Device Details
Registration Details
240000044/PCBB-BYT
000.00.04.G18-240320-0008
Theo theo phụ lục
Theo phụ lục
Technical Details
The IVD Quantitative Ethanol Test Kit consists of the following components: (1) Ethanol Quantitation Test Reagent (VITROS Chemistry Products ALC Slides): Used in in vitro diagnostic testing to quantitate the concentration of ethanol (ALC) in serum and plasma on the VITROS 250/350/5,1 FS/4600/XT 3400 systems and the integrated VITROS 5600/XT 7600 systems. (2) Ethanol Quantitation Test Calibration Kit (VITROS Chemistry Products Calibrator Kit 8): Used in in vitro diagnostic testing to calibrate the VITROS 250/350/5,1 FS/4600/XT 3400 systems and the integrated VITROS 5600/XT 7600 systems when quantitating the concentration of ethanol (ALC).
Dates and Status
Mar 26, 2024