Automatic Biochemical Analyzer
Vietnam·Risk Class TTBYT Loại C·INDIKO·Thermo Fisher Scientific Oy·Registered Nov 14, 2024- Analysis ID
- 2403575ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-231129-0001
- Product Type
- INDIKO
- Product Code
- 98630000
- Manufacturer
- Thermo Fisher Scientific Oy
- Manufacturer Country
- FINLAND
- Authorized Representative
- CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM
- Intended Use
- Thermo Scientific Indiko Clinical Biochemistry Workstations are fully automated random access workstations for routine and special biochemical assays, including specific proteins, therapeutic drugs, and drugs of abuse. Indiko Clinical Biochemistry Workstations are intended to be used in the diagnosis of disease or other conditions, including the determination of health status, for the purpose of treatment, mitigation, therapy, or prevention of disease. Indiko and all reagents in this system are intended only for research diagnostic use in the laboratory. The device is intended to be used by trained personnel who have basic knowledge of the operation of the workstations.
- Registration Date
- Nov 14, 2024
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Access comprehensive regulatory information for Automatic Biochemical Analyzer in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2403575ĐKLH/BYT-HTTB and manufactured by Thermo Fisher Scientific Oy. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM.
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