IVD Department for Quantitative RF Testing
Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Beckman Coulter, Inc.·Registered Sep 23, 2024- Analysis ID
- 240002503/PCBB-HN
- Submission ID
- 000.00.19.H26-240918-0003
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Beckman Coulter, Inc.
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Beckman Coulter, Inc.
- Authorized Representative
- CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG
- Intended Use
- RF LATEX: RF Latex is an in vitro diagnostic medical device used by healthcare professionals to quantify RF (low-form factor) in human serum and plasma by the turbidimetric immunoassay method, using Beckman Coulter's AU/DxC AU automated analyzers. The measurement of RF Latex is used in the support of diagnosing rheumatoid arthritis. RF LATEX CALIBRATOR: RF Latex Calibrator is a liquid human serum albumin-based calibrator used with the RF Latex OSR61105 reagent to quantify the low-form factor, using Beckman Coulter's AU/DxC AU automated analyzers.
- Registration Date
- Sep 23, 2024
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Access comprehensive regulatory information for IVD Department for Quantitative RF Testing 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 240002503/PCBB-HN and manufactured by Beckman Coulter, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG.
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