Vietnam MOH registration 240000677/PCBB-HN

IVD Department, Quantitative Fructosamine (FRUC) Testing

VN: Bộ IVD xét nghiệm định lượng Fructosamine (FRUC)

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·BEIJING STRONG BIOTECHNOLOGIES, INC.·Registered Mar 28, 2024

Registration details

Analysis ID: 240000677/PCBB-HN
Submission ID: 000.00.19.H26-240326-0007
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 ĐẦU TƯ VÀ THIẾT BỊ THIÊN AN

Technical details

Intended Use: - Fructosamine (FRUC) Test: Used in in vitro diagnosis to determine the quantitative concentration of fructosamine in serum. - Fructosamine (FRUC) Calibration Standard: This is the calibration standard of the Fructosamine (FRUC) test kit and is intended for in vitro diagnosis only. - Fructosamine (FRUC) Control Material: This is the control material of the Fructosamine (FRUC) test kit and is intended for in vitro diagnosis only.

Dates and status

Registration Date: Mar 28, 2024

About this record

Access comprehensive regulatory information for IVD Department, Quantitative Fructosamine (FRUC) Testing 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 240000677/PCBB-HN and manufactured by BEIJING STRONG BIOTECHNOLOGIES, INC.. The authorized representative in Vietnam is CÔNG TY TNHH ĐẦU TƯ VÀ THIẾT BỊ THIÊN AN.

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