Vietnam MOH registration 240000045/PCBB-BYT
Quantitative Test Control Material for Total T3, Total T4, TSH, Absorbed T3
VN: Vật liệu kiểm soát xét nghiệm định lượng T3 tổng số, T4 tổng số, TSH, T3 hấp thụ
Vietnam·Risk Class TTBYT Loại B·VITROS Immunodiagnostic Products Total Thyroid Controls·Ortho-Clinical Diagnostics·Registered Mar 26, 2024Registration details
- Analysis ID
- 240000045/PCBB-BYT
- Submission ID
- 000.00.04.G18-240326-0006
- Product Type
- VITROS Immunodiagnostic Products Total Thyroid Controls
- Product Code
- 1410646
Company information
- Manufacturer
- Ortho-Clinical Diagnostics
- Manufacturer Country
- Pencoed Bridgend CF35 5PZ
- Product Owner
- Ortho-Clinical Diagnostics
- Authorized Representative
- CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM
Technical details
- Intended Use
- VITROS Immunodiagnostic Products Total Thyroid Controls are used in in vitro diagnosis to monitor the activity of the VITROS ECi/ECiQ/3600 and the integrated VITROS 5600/XT 7600 systems when quantifying TSH, total T3, total T4, and evaluating the binding capacity of thyroid hormones.
Dates and status
- Registration Date
- Mar 26, 2024
About this record
Access comprehensive regulatory information for Quantitative Test Control Material for Total T3, Total T4, TSH, Absorbed T3 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 240000045/PCBB-BYT and manufactured by Ortho-Clinical Diagnostics. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM.
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