Vietnam MOH registration 220003057/PCBB-BYT

HbA1c Quantitative Analysis Column

VN: Cột phân tích xét nghiệm định lượng HbA1c

Vietnam·Risk Class TTBYT Loại B·Premier Hb9210 HbA1c Analytical Column (1000)·Trinity Biotech·Registered Sep 22, 2022

Registration details

Analysis ID: 220003057/PCBB-BYT
Submission ID: 000.00.04.G18-220922-0002
Product Type: Premier Hb9210 HbA1c Analytical Column (1000)
Product Code: 09-06-0046

Company information

Manufacturer: Trinity Biotech
Manufacturer Country: USA

Technical details

Intended Use: The analysis column used on the Premier Hb9210 HbA1c Analyzer of Trinity Biotech. The product is not intended for any other use, nor has it been authorized or licensed for any other purpose. The Premier Hb9210 system is used to quantify hemoglobin A1c (HbA1c) in whole blood samples from humans (venous or capillary blood samples). The HbA1c test is used to monitor the long-term control of blood glucose in diabetic patients. The product is intended for in vitro diagnostic use only.

Dates and status

Registration Date: Sep 22, 2022

About this record

Access comprehensive regulatory information for HbA1c Quantitative Analysis Column 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 220003057/PCBB-BYT and manufactured by Trinity Biotech.

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