Vietnam MOH registration 240000044/PCBB-BYT
IVD Department quantitative Ethanol testing
VN: Bộ IVD xét nghiệm định lượng Ethanol
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Ortho-Clinical Diagnostics, Inc.·Registered Mar 26, 2024Registration details
- Analysis ID
- 240000044/PCBB-BYT
- Submission ID
- 000.00.04.G18-240320-0008
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
Company information
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Ortho-Clinical Diagnostics, Inc.
- Authorized Representative
- CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM
Technical details
- Intended Use
- 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
- Registration Date
- Mar 26, 2024
About this record
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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