Vietnam MOH registration 240001739/PCBA-HCM

Nucleic Acid Extraction System and Automated Real Time PCR

VN: Hệ thống tách chiết nucleic acid và real time PCR tự động

Automated Nucleic Acid Purification and Real Time PCR System

Vietnam·Risk Class TBYT Loại A·Real time PCR separation machine·HANGZHOU BIOER TECHNOLOGY CO., LTD·Registered Nov 12, 2024

Registration details

Analysis ID: 240001739/PCBA-HCM
Submission ID: 000.00.19.H29-241107-0016
Product Type: Real time PCR separation machine
Product Code: FQD-A1600

Company information

Manufacturer: HANGZHOU BIOER TECHNOLOGY CO., LTD
Manufacturer Country: CHINA
Product Owner: HANGZHOU BIOER TECHNOLOGY CO., LTD
Authorized Representative: CÔNG TY CỔ PHẦN CÔNG NGHỆ TBR

Technical details

Intended Use: Used for the extraction, purification, and real-time PCR analysis of nucleic acids from clinical samples such as whole blood, serum, plasma, urine, and surface swabs from humans. The equipment used for qualitative and quantitative detection of the components in the DNA/RNA of the extracted nucleic acids, including both clinical samples and human genes. It is used in clinical laboratories, hospitals, ... for in vitro diagnostic purposes.

Dates and status

Registration Date: Nov 12, 2024

About this record

Access comprehensive regulatory information for Nucleic Acid Extraction System and Automated Real Time PCR in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại A medical device is registered under number 240001739/PCBA-HCM and manufactured by HANGZHOU BIOER TECHNOLOGY CO., LTD. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN CÔNG NGHỆ TBR.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.