Vietnam MOH registration 240000043/PCBB-BYT
Calibration Standard for Quantitative Analysis of 7 Biochemical Indices
VN: Chất hiệu chuẩn xét nghiệm định lượng 7 chỉ số sinh hóa
Registration details
- Analysis ID
- 240000043/PCBB-BYT
- Submission ID
- 000.00.04.G18-240320-0005
- Product Type
- VITROS Chemistry Products Calibrator Kit 4
- Product Code
- 1204668
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 biochemical test system and the integrated VITROS 5600/XT 7600 system when quantifying Albumin, Conjugated Bilirubin and Unconjugated Bilirubin, Iron, Total Bilirubin, and Total Iron Binding Capacity (TIBC), Total Protein
Dates and status
- Registration Date
- Mar 20, 2024
About this record
Access comprehensive regulatory information for Calibration Standard for Quantitative Analysis of 7 Biochemical Indices 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 240000043/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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