Vietnam MOH registration 2400885ĐKLH/BYT-HTTB

IVD Department qualitative DNA test for Group B Streptococcus (GBS)

VN: Bộ IVD xét nghiệm định tính ADN của Liên cầu khuẩn nhóm B (GBS)

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·DiaSorin Molecular LLC·Registered Jun 24, 2024

Registration details

Analysis ID: 2400885ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-210408-0026
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: DiaSorin Molecular LLC
Manufacturer Country: Theo theo phụ lục
Product Owner: DiaSorin Molecular LLC
Authorized Representative: CÔNG TY TNHH THIẾT BỊ NHẬT ANH

Technical details

Intended Use: 1. Simplexa GBS Direct: The Simplexa GBS Direct test from DiaSorin Molecular is performed on the LIAISON MDX device to detect the presence of nucleic acid of Group B Streptococcus (GBS) in the vaginal/rectal swab of pregnant women, enriched in Lim Broth culture medium from 18 to 24 hours. The test results can be used to support the determination of the colonization status of the bacteria in pregnant women, but are not intended for the diagnosis or monitoring of GBS infection. 2. Simplexa GBS Positive Control Pack: The Simplexa GBS Positive Control Pack is used as a control material for the Simplexa GBS Direct test. Do not use this control material in conjunction with any other test or system.

Dates and status

Registration Date: Jun 24, 2024

About this record

Access comprehensive regulatory information for IVD Department qualitative DNA test for Group B Streptococcus (GBS) 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 2400885ĐKLH/BYT-HTTB and manufactured by DiaSorin Molecular LLC. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ NHẬT ANH.

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