Vietnam MOH registration 2400497ĐKLH/BYT-HTTB

M. Tuberculosis drug-resistant complex qualitative test

VN: Thuốc thử xét nghiệm định tính phức hợp M. Tuberculosis đa kháng thuốc

GenoType MTBDRplus VER 2.0

Vietnam·Risk Class TTBYT Loại C·GenoType MTBDRplus VER 2.0·Hain Lifescience GmbH·Registered Apr 10, 2024

Registration details

Analysis ID: 2400497ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-220714-0018
Product Type: GenoType MTBDRplus VER 2.0
Product Code: 304A/30496A

Company information

Manufacturer: Hain Lifescience GmbH
Manufacturer Country: GERMANY
Product Owner: Hain Lifescience GmbH
Authorized Representative: CÔNG TY TNHH B.C.E VIỆT NAM

Technical details

Intended Use: GenoType MTBDRplus VER 2.0 is an in vitro qualitative test to determine the complex of Mycobacterium tuberculosis and the ability to resist rifampicin (RMP) and/or isoniazid (INH) from clinical positive or positive lung samples and culture samples.

Dates and status

Registration Date: Apr 10, 2024

About this record

Access comprehensive regulatory information for M. Tuberculosis drug-resistant complex qualitative test 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 2400497ĐKLH/BYT-HTTB and manufactured by Hain Lifescience GmbH. The authorized representative in Vietnam is CÔNG TY TNHH B.C.E VIỆT NAM.

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