Vietnam MOH registration 240000957/PCBB-HN

Fluorescent Immunoassay Testing Machine

VN: Máy xét nghiệm miễn dịch huỳnh quang

Vietnam·Risk Class TTBYT Loại B·BIOT-YG-I FIA Analyzer·Xiamen Biotime Biotechnology Co., Ltd·Registered May 07, 2024

Registration details

Analysis ID: 240000957/PCBB-HN
Submission ID: 000.00.19.H26-240422-0020
Product Type: BIOT-YG-I FIA Analyzer
Product Code: BIOT-YG-I

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: The fluorescent immunoassay analyzer BIOT-YG-I, produced by Xiamen Biotime Biotechnology Co., Ltd., is a handheld device used to detect fluorescence in order to quantify the concentration of various types of analytes in blood or urine. This device is intended for in vitro diagnostic use only. The fluorescent immunoassay analyzer BIOT-YG-I is designed for professional use.

Dates and status

Registration Date: May 07, 2024

About this record

Access comprehensive regulatory information for Fluorescent Immunoassay Testing Machine 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 240000957/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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