HbA1c Quantitative Testing Control Material Kit - Vietnam Registration 240001651/PCBB-HN
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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Device Details
Registration Details
240001651/PCBB-HN
000.00.19.H26-240703-0025
Theo theo phụ lục
Theo phụ lục
Technical Details
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
Jul 10, 2024