Magnesium (Mg) and Ammonia Electrolysis Drug Test Cluster IVD - Vietnam Registration 240000048/PCBB-BYT
Access comprehensive regulatory information for Magnesium (Mg) and Ammonia Electrolysis Drug Test Cluster IVD 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 240000048/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
240000048/PCBB-BYT
000.00.04.G18-240401-0005
Theo theo phụ lục
Theo phụ lục
Technical Details
The IVD drug test group for Magnesium (Mg) and Ammonia, consisting of the following components: (1) The quantitative Mg test slide (VITROS Chemistry Products Mg Slides): Used in in vitro diagnostic testing to quantitate the concentration of Magnesium (Mg) in serum, plasma, and urine on the VITROS 250/350/5,1 FS/4600/XT 3400 systems and the integrated VITROS 5600/XT 7600 systems. (2) The quantitative Ammonia test slide (VITROS Chemistry Products AMON Slides): Used in in vitro diagnostic testing to measure the concentration of ammonia in serum on the VITROS 250/350/5,1 FS/4600, XT 3400 systems and the integrated VITROS 5600/XT 7600 systems.
Dates and Status
Apr 03, 2024