Vietnam MOH registration 2403183ĐKLH/BYT-HTTB
Qualitative DNA Testing of Mycobacterium tuberculosis
VN: Thuốc thử xét nghiệm định tính ADN của Mycobacterium tuberculosis
Vietnam·Risk Class TTBYT Loại C·AccuPower® MTB Real-Time PCR Kit·Bioneer Corporation·Registered Nov 02, 2024Registration details
- Analysis ID
- 2403183ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-201211-0010
- Product Type
- AccuPower® MTB Real-Time PCR Kit
- Product Code
- MTB-1111
Company information
- Manufacturer
- Bioneer Corporation
- Manufacturer Country
- REPUBLIC OF
- Product Owner
- Bioneer Corporation
- Authorized Representative
- CÔNG TY CỔ PHẦN Y TẾ ĐỨC MINH
Technical details
- Intended Use
- AccuPower® MTB Real-Time PCR Kit is an in vitro diagnostic kit designed to detect the DNA of Mycobacterium tuberculosis (MTB) in clinical samples: sputum, bronchoalveolar lavage (BAL) or urine through real-time polymerase chain reaction (PCR). This kit is a qualitative test intended for professional use only.
Dates and status
- Registration Date
- Nov 02, 2024
About this record
Access comprehensive regulatory information for Qualitative DNA Testing of Mycobacterium tuberculosis 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 2403183ĐKLH/BYT-HTTB and manufactured by Bioneer Corporation. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN Y TẾ ĐỨC MINH.
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