Vietnam MOH registration 240002093/PCBB-HN

IVD Department quantitative Hemoglobin A1c (HbA1c)

VN: Bộ IVD xét nghiệm định lượng Hemoglobin A1c (HbA1c)

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·BEIJING STRONG BIOTECHNOLOGIES, INC.·Registered Aug 16, 2024

Registration details

Analysis ID: 240002093/PCBB-HN
Submission ID: 000.00.19.H26-240812-0026
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: BEIJING STRONG BIOTECHNOLOGIES, INC.
Manufacturer Country: Theo theo phụ lục
Product Owner: BEIJING STRONG BIOTECHNOLOGIES, INC.
Authorized Representative: CÔNG TY TNHH THIẾT BỊ CÔNG NGHỆ HKT

Technical details

Intended Use: Hemoglobin A1c (HbA1c) Quantitative Test: A test used to determine the quantitative concentration of HbA1c/total hemoglobin (%) in human blood. *Hemoglobin A1c Quantitative Test Calibration Standard: This is the calibration standard of the HbA1c quantitative test kit. *Quantitative Control Material for Hemoglobin A1c (HbA1c): This is the quantitative control material of the HbA1c quantitative test kit

Dates and status

Registration Date: Aug 16, 2024

About this record

Access comprehensive regulatory information for IVD Department quantitative Hemoglobin A1c (HbA1c) 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 240002093/PCBB-HN and manufactured by BEIJING STRONG BIOTECHNOLOGIES, INC.. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ CÔNG NGHỆ HKT.

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