Vietnam MOH registration 240001651/PCBB-HN
HbA1c Quantitative Testing Control Material Kit
VN: Bộ thuốc thử, vật liệu kiểm soát xét nghiệm định lượng HbA1c
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·i-SENS, Inc·Registered Jul 10, 2024Registration details
- Analysis ID
- 240001651/PCBB-HN
- Submission ID
- 000.00.19.H26-240703-0025
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
Company information
- Manufacturer
- i-SENS, Inc
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- i-SENS, Inc
- Authorized Representative
- CÔNG TY TNHH VIỆT PHAN
Technical details
- Intended Use
- The A1Care HbA1c Cartridge is used to quantitate the amount of glycated hemoglobin (HbA1c) and the percentage (or mmol/mol) of HbA1c relative to the total hemoglobin (tHb) in capillary and venous blood samples using the A1Care analyzer. The A1Care HbA1c Cartridge is used in vitro diagnostic (IVD) by medical specialists in laboratories, such as clinics and hospitals, for the diagnosis of diabetes in patients; the A1Care HbA1c Control Solution is used together with the A1Care analyzer and A1Care HbA1c Cartridge to monitor the performance and accuracy of the HbA1c determination methods. The A1Care HbA1c Control Solution is used in vitro diagnostic (IVD) by medical laboratory personnel, such as in clinics and hospitals.
Dates and status
- Registration Date
- Jul 10, 2024
About this record
Access comprehensive regulatory information for HbA1c Quantitative Testing Control Material Kit 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 240001651/PCBB-HN and manufactured by i-SENS, Inc. The authorized representative in Vietnam is CÔNG TY TNHH VIỆT PHAN.
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