Vietnam MOH registration 2400200ĐKLH/BYT-HTTB

Qualitative DNA Test for Mycobacterium tuberculosis -MTB and Non-tuberculosis Mycobacteria - NTM

VN: Bộ xét nghiệm định tính ADN Mycobacterium tuberculosis -MTB và non-tuberculosis Mycobacteria - NTM

Vietnam·Risk Class TTBYT Loại C·Anyplex™ MTB/NTM Combi·Seegene, Inc.·Registered Feb 04, 2024

Registration details

Analysis ID: 2400200ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-211104-0023
Product Type: Anyplex™ MTB/NTM Combi
Product Code: TB7203Y

Company information

Manufacturer: Seegene, Inc.
Manufacturer Country: REPUBLIC OF
Authorized Representative: CÔNG TY TNHH THIẾT BỊ Y TẾ PHƯƠNG ĐÔNG

Technical details

Intended Use: In vitro qualitative testing to detect Mycobacterium tuberculosis (MTB) and atypical non-tuberculosis mycobacteria (NTM) from sputum samples.

Dates and status

Registration Date: Feb 04, 2024

About this record

Access comprehensive regulatory information for Qualitative DNA Test for Mycobacterium tuberculosis -MTB and Non-tuberculosis Mycobacteria - NTM in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2400200ĐKLH/BYT-HTTB and manufactured by Seegene, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ PHƯƠNG ĐÔNG.

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.