Vietnam MOH registration 240000056/PCBB-BYT
Protein Cerebrospinal Fluid Quantitative Testing Drug
VN: Thuốc thử xét nghiệm định lượng Protein dịch não tủy
Registration details
- Analysis ID
- 240000056/PCBB-BYT
- Submission ID
- 000.00.04.G18-240401-0006
- Product Type
- VITROS Chemistry Products PROT Slides
- Product Code
- 8208431
Company information
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Manufacturer Country
- New York 14626
- 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 diagnosis to quantify the concentration of protein (PROT) in cerebrospinal fluid using the VITROS 250/350/5.1 FS/4600/XT 3400 biochemical assay system and the VITROS 5600/XT 7600 integrated system.
Dates and status
- Registration Date
- Apr 11, 2024
About this record
Access comprehensive regulatory information for Protein Cerebrospinal Fluid Quantitative Testing Drug 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 240000056/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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