Vietnam MOH registration 240000959/PCBB-HN

Quantitative HCY Test Drug

VN: Thuốc thử xét nghiệm định lượng HCY

Vietnam·Risk Class TTBYT Loại B·HCY Rapid Quantitative Test·Xiamen Biotime Biotechnology Co., Ltd·Registered May 07, 2024

Registration details

Analysis ID: 240000959/PCBB-HN
Submission ID: 000.00.19.H26-240422-0026
Product Type: HCY Rapid Quantitative Test
Product Code: BT2221

Company information

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd
Product Owner: Xiamen Biotime Biotechnology Co., Ltd
Authorized Representative: CÔNG TY CỔ PHẦN Y TẾ VIỆT

Technical details

Intended Use: HCY Rapid Quantitative Test is used to quantitate the concentration of HCY in human serum on the FIA Biotime Immunoassay Fluorescence Analyzer by Fluorescence Immunoassay. This test is used as a supportive diagnostic method for homocysteine blood disease.

Dates and status

Registration Date: May 07, 2024

About this record

Access comprehensive regulatory information for Quantitative HCY Test Drug 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 240000959/PCBB-HN and manufactured by Xiamen Biotime Biotechnology Co., Ltd. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN Y TẾ VIỆT.

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