Drug Testing, Control Material, Diagnostic Reference Standard for In Vitro Use in Chromatographic Analysis Machines
Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Shanghai Kehua Bio-Engineering Co., Ltd.·Registered Sep 12, 2024- Analysis ID
- 240000020/PCBB-HP
- Submission ID
- 000.00.18.H24-240819-0002
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Shanghai Kehua Bio-Engineering Co., Ltd.
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Shanghai Kehua Bio-Engineering Co., Ltd.
- Authorized Representative
- CÔNG TY TNHH CÔNG NGHỆ TIANLONG VIỆT NAM
- Intended Use
- System Calibrator Level 2 is designed to be used as a calibrator for multiple clinical chemistry tests KHB. Control Serum Level 1 is used as a quality control measure for multiple clinical chemistry tests KHB. Control Serum Level 2 is used as a quality control measure for multiple clinical chemistry tests KHB. Enzyme Multical Calibrator is intended to be used as a calibrator for multiple clinical chemistry tests KHB. Enzyme Multical Control is intended to be used as a quality control measure for multiple clinical chemistry tests KHB. Immunology Multi Control is intended to be used as a quality control measure for multiple clinical chemistry tests KHB. Lipid Quality Control is intended to be used as a quality control measure for multiple clinical chemistry tests KHB. Rheumatism Multi Control is intended to be used as a quality control measure for multiple clinical chemistry tests KHB. Urinary Control is intended to be used as a quality control measure for multiple clinical chemistry tests KHB.
- Registration Date
- Sep 12, 2024
Access comprehensive regulatory information for Drug Testing, Control Material, Diagnostic Reference Standard for In Vitro Use in Chromatographic Analysis Machines in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240000020/PCBB-HP and manufactured by Shanghai Kehua Bio-Engineering Co., Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH CÔNG NGHỆ TIANLONG VIỆT NAM.
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