Vietnam MOH registration 240000030/PCBB-LA

Qualitative DNA Virus Testing Chemical Kit

VN: Bộ hóa chất xét nghiệm định tính DNA virus

TopSENSI ® HSV 1-2 multiplex qPCR Kit

Vietnam·Risk Class TBYT Loại B·Kit Real-time PCR·ABT Biotech Solution Co., Ltd. - Long Hậu Branch·Registered Sep 23, 2024

Registration details

Analysis ID: 240000030/PCBB-LA
Submission ID: 000.00.17.H39-240912-0002
Product Type: Kit Real-time PCR
Product Code: ADS-004

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: Used to detect the presence of HSV1 and HSV2 DNA in samples extracted from different clinical samples from humans by real-time PCR. The test results of this kit are intended only as a clinical reference and will not be used as the sole basis for diagnosis or exclusion

Dates and status

Registration Date: Sep 23, 2024

About this record

Access comprehensive regulatory information for Qualitative DNA Virus Testing Chemical Kit 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 240000030/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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