Vietnam MOH registration 240000024/PCBB-LA

Automated Fluorescent Molecular Biology Testing System

VN: Hệ thống xét nghiệm sinh học phân tử tự động

Fully Automated Molecular Detection System

Vietnam·Risk Class TTBYT Loại B·System of Extraction and Automated Real-time PCR·ABT Biotech Solution Co., Ltd. - Long Hậu Branch·Registered Jul 26, 2024

Registration details

Analysis ID: 240000024/PCBB-LA
Submission ID: 000.00.17.H39-240723-0001
Product Type: System of Extraction and Automated Real-time PCR
Product Code: EZ01

Company information

Manufacturer: ABT Biotech Solution Co., Ltd. - Long Hậu Branch
Product Owner: CÔNG TY TNHH GIẢI PHÁP Y SINH ABT- CHI NHÁNH LONG HẬU
Authorized Representative: CÔNG TY TNHH GIẢI PHÁP Y SINH ABT- CHI NHÁNH LONG HẬU

Technical details

Intended Use: The use of DNA/RNA extraction and target detection by real-time PCR. The results of this automated molecular biology testing system are intended for clinical reference only, and the decision on treatment is usually made after a more in-depth evaluation

Dates and status

Registration Date: Jul 26, 2024

About this record

Access comprehensive regulatory information for Automated Fluorescent Molecular Biology Testing System 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 240000024/PCBB-LA and manufactured by ABT Biotech Solution Co., Ltd. - Long Hậu Branch. The authorized representative in Vietnam is CÔNG TY TNHH GIẢI PHÁP Y SINH ABT- CHI NHÁNH LONG HẬU.

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