Vietnam MOH registration 240000688/PCBB-HN
IVD Cluster for Anemia: Ferritin, Transferrin
VN: Cụm IVD Bệnh thiếu máu: Ferritin, Transferrin
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Beckman Coulter, Inc.·Registered Mar 28, 2024Registration details
- Analysis ID
- 240000688/PCBB-HN
- Submission ID
- 000.00.19.H26-240229-0018
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
Company information
- Manufacturer
- Beckman Coulter, Inc.
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Beckman Coulter, Inc.
- Authorized Representative
- CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG
Technical details
- Intended Use
- 1. Ferritin: Ferritin test is an in vitro diagnostic medical device used by medical specialists to quantify ferritin in human serum and plasma by the turbidimetric immunodetection method, on the Beckman Coulter AU/DxC AU automated analyzers. The measurement of ferritin is used in the diagnostic support of iron deficiency anemia and iron overload disorders. 2. Transferrin: Transferrin test is an in vitro diagnostic medical device used by medical specialists to quantify transferrin in human serum and plasma, on the Beckman Coulter AU/DxC AU automated analyzers. The measurement of transferrin is used in the diagnostic support of anemia and anemia due to iron transport deficiency.
Dates and status
- Registration Date
- Mar 28, 2024
About this record
Access comprehensive regulatory information for IVD Cluster for Anemia: Ferritin, Transferrin 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 240000688/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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