Vietnam MOH registration 2403566ĐKLH/BYT-HTTB
Quantitative Test for Fibrin Degradation Products (D-Dimer and X-Oligomer)
VN: Thuốc thử xét nghiệm định lượng sản phẩm giáng hóa fibrin (D‑Dimer và X‑oligomer)
Vietnam·Risk Class TTBYT Loại C·D-DI2·Roche Diagnostics GmbH·Registered Nov 14, 2024Registration details
- Analysis ID
- 2403566ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-240814-0008
- Product Type
- D-DI2
- Product Code
- 05172381190
Company information
- Manufacturer
- Roche Diagnostics GmbH
- Manufacturer Country
- GERMANY
- Authorized Representative
- CÔNG TY TNHH ROCHE VIỆT NAM
Technical details
- Intended Use
- In vitro testing used to quantify the degradation products of fibrin (D-Dimer and X-oligomer) in human blood plasma on cobas systems. Combined with the clinical evaluation of low probability, a normal result (<0.5µg FEUa)/mL) excludes deep vein thrombosis (DVT) and pulmonary embolism (PE) with high sensitivity. a) Equivalent units of Fibrinogen
Dates and status
- Registration Date
- Nov 14, 2024
About this record
Access comprehensive regulatory information for Quantitative Test for Fibrin Degradation Products (D-Dimer and X-Oligomer) 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 2403566ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics GmbH. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
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