Vietnam MOH registration 240000037/PCBB-LA

Qualitative DNA Test Kit for Vibrio vulnificus

VN: Bộ xét nghiệm định tính DNA Vibrio vulnificus

TopSENSI ® Vibrio vulnificus qPCR Kit

Vietnam·Risk Class TBYT Loại B·Kit Real-time PCR·ABT Biotech Solution Co., Ltd. - Long Hậu Branch·Registered Nov 21, 2024

Registration details

Analysis ID: 240000037/PCBB-LA
Submission ID: 000.00.17.H39-241113-0002
Product Type: Kit Real-time PCR
Product Code: SQH-146

Company information

Manufacturer: ABT Biotech Solution Co., Ltd. - Long Hậu Branch
Product Owner: CÔNG TY TNHH GIẢI PHÁP Y SINH ABT- CHI NHÁNH LONG HẬU
Authorized Representative: CÔNG TY TNHH GIẢI PHÁP Y SINH ABT- CHI NHÁNH LONG HẬU

Technical details

Intended Use: It is used to detect the presence of DNA of Vibrio vulnificus in the sample extracted from different samples of human by real-time PCR technique. The test results of this test kit are only for clinical reference and will not be used as the sole basis for diagnosis or exclusion.

Dates and status

Registration Date: Nov 21, 2024

About this record

Access comprehensive regulatory information for Qualitative DNA Test Kit for Vibrio vulnificus in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240000037/PCBB-LA and manufactured by ABT Biotech Solution Co., Ltd. - Long Hậu Branch. The authorized representative in Vietnam is CÔNG TY TNHH GIẢI PHÁP Y SINH ABT- CHI NHÁNH LONG HẬU.

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