Vietnam MOH registration 240000041/PCBB-BYT
HDL Cholesterol Quantification Test Calibration Standard
VN: Chất hiệu chuẩn xét nghiệm định lượng HDL Cholesterol
Vietnam·Risk Class TTBYT Loại B·VITROS Chemistry Products Calibrator Kit 25·Ortho-Clinical Diagnostics, Inc.·Registered Mar 20, 2024Registration details
- Analysis ID
- 240000041/PCBB-BYT
- Submission ID
- 000.00.04.G18-240319-0002
- Product Type
- VITROS Chemistry Products Calibrator Kit 25
- Product Code
- 6801896
Company information
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Manufacturer Country
- New York 14606
- Product Owner
- Ortho-Clinical Diagnostics, Inc.
- Authorized Representative
- CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM
Technical details
- Intended Use
- Used in in vitro diagnostic to calibrate the VITROS 250/350/5,1 FS/4600/XT 3400 biochemical test system and the VITROS 5600/XT 7600 integrated system when quantifying HDL Cholesterol using VITROS Chemistry Products dHDL Slides
Dates and status
- Registration Date
- Mar 20, 2024
About this record
Access comprehensive regulatory information for HDL Cholesterol Quantification Test Calibration Standard 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 240000041/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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