Qualitative DNA Test Kit for Mycobacterium tuberculosis -MTB and Drug Resistance Mutations
Vietnam·Risk Class TTBYT Loại C·Anyplex™ II MTB/MDR/XDR Detection·Seegene, Inc.·Registered Apr 10, 2024- Analysis ID
- 2400519ĐKLH/BYT-HTTB
- Submission ID
- 20011117/ĐKLH-BYT-TB-CT
- Product Type
- Anyplex™ II MTB/MDR/XDR Detection
- Product Code
- TB7500Y
- Manufacturer
- Seegene, Inc.
- Manufacturer Country
- REPUBLIC OF
- Authorized Representative
- CÔNG TY TNHH THIẾT BỊ Y TẾ PHƯƠNG ĐÔNG
- Intended Use
- Anyplex™ II MTB/MDR/XDR Detection is a qualitative in vitro diagnostic test designed to simultaneously detect Mycobacterium tuberculosis (MTB) and the resistance to first-line anti-tuberculosis drugs (Isoniazid and Rifampicin) and second-line anti-tuberculosis drugs (Fluoroquinolones and injectable drugs) from sputum, culture broth, fresh tissue, or bronchoalveolar lavage fluid samples from symptomatic patients. Drug resistance mutations include: 7 mutations conferring resistance to Isoniazid on the katG gene and the inhA promoter region, 18 mutations conferring resistance to Rifampicin on the rpoB gene, 7 mutations conferring resistance to Fluoroquinolones on the gyrA gene, and 6 mutations conferring resistance to injectable drugs on the rrs gene and the eis promoter region.
- Registration Date
- Apr 10, 2024
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Access comprehensive regulatory information for Qualitative DNA Test Kit for Mycobacterium tuberculosis -MTB and Drug Resistance Mutations 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 2400519ĐKLH/BYT-HTTB and manufactured by Seegene, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ PHƯƠNG ĐÔNG.
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