Materials for the determination of Prothrombin Time, Activated Partial Thromboplastin Time (APTT), Thrombin Time, and Quantification of Fibrinogen
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Biolabo SAS·Registered Aug 27, 2024- Analysis ID
- 2402223ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-210622-0004
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Biolabo SAS
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Biolabo SAS
- Authorized Representative
- CÔNG TY TNHH THIẾT BỊ Y TẾ PHƯƠNG ĐÔNG
- Intended Use
- BE Trol 1/ Plasma Level 1 (773100): This chemical is used in the laboratory (both automated and semi-automated methods). BE Trol 1 Plasma Level 1 is used as a calibrator for blood coagulation tests using the BE chemical. BE Trol 2/ Plasma Level 2 (773101): This chemical is used in the laboratory (both automated and semi-automated methods). BE Trol 2 Plasma Level 2 is used as a calibrator for blood coagulation tests using the BE chemical.
- Registration Date
- Aug 27, 2024
Access comprehensive regulatory information for Materials for the determination of Prothrombin Time, Activated Partial Thromboplastin Time (APTT), Thrombin Time, and Quantification of Fibrinogen 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 2402223ĐKLH/BYT-HTTB and manufactured by Biolabo SAS. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ PHƯƠNG ĐÔNG.
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