Vietnam MOH registration 240002092/PCBB-HN

IVD Department quantitative C - reactive protein test

VN: Bộ IVD xét nghiệm định lượng C - reactive protein

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

Registration details

Analysis ID: 240002092/PCBB-HN
Submission ID: 000.00.19.H26-240521-0042
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: - Quantitative C-reactive Protein (CRP) and High sensitive C-reactive Protein (HCRP) Test: Used for in vitro diagnosis to determine the concentration of C-reactive Protein in serum or plasma of humans - Calibration Standard for Quantitative C-reactive Protein (CRP) and High sensitive C-reactive Protein (HCRP) Test: This is the calibration standard of the quantitative C-reactive Protein test kit, intended for in vitro diagnosis only. - Quantitative C-reactive Protein (CRP) and High sensitive C-reactive Protein (HCRP) Control Material: This is the control material of the quantitative C-reactive Protein test kit, intended for in vitro diagnosis only.

Dates and status

Registration Date: Aug 16, 2024

About this record

Access comprehensive regulatory information for IVD Department quantitative C - reactive protein test 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 240002092/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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