Vietnam MOH registration 240001735/PCBA-HCM

6-channel color real-time PCR system

VN: Hệ thống máy real time PCR 6 kênh màu

QuantGene 9600 Fluorescent Quantitative Detection System

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

Registration details

Analysis ID: 240001735/PCBA-HCM
Submission ID: 000.00.19.H29-241107-0021
Product Type: Real-time PCR Machine
Product Code: FQD-96C

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: It is used for the detection and quantification of nucleic acids in clinical and hospital laboratories, etc. The samples may be throat swab and tonsil swab, whole blood, serum, plasma, saliva sample, etc. This device is intended for in vitro diagnostic use only.

Dates and status

Registration Date: Nov 12, 2024

About this record

Access comprehensive regulatory information for 6-channel color real-time PCR system 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 240001735/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.