Vietnam MOH registration 240001099/PCBB-HN

IVD Department quantitative Ammonia (AMM)

VN: Bộ IVD xét nghiệm định lượng Ammonia (AMM)

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·BEIJING STRONG BIOTECHNOLOGIES, INC.·Registered May 18, 2024

Registration details

Analysis ID: 240001099/PCBB-HN
Submission ID: 000.00.19.H26-240509-0019
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: -Ammonia Quantification Test (AMM): Used in in vitro diagnosis to determine the concentration of ammonia in blood. -Ammonia Quantification Test Calibration Standard (AMM): This is the calibration standard of the Ammonia Quantification Test (AMM), intended for in vitro diagnosis only. -Ammonia Quantification Test Control Material (AMM): This is the control material of the Ammonia Quantification Test (AMM), intended for in vitro diagnosis only.

Dates and status

Registration Date: May 18, 2024

About this record

Access comprehensive regulatory information for IVD Department quantitative Ammonia (AMM) 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 240001099/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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