Vietnam MOH registration 240000162/PCBA-HN

Kit for the preliminary processing of positive blood samples

VN: Bộ kit tiền xử lí cho mẫu máu dương tính

Vietnam·Risk Class TTBYT Loại A·Theo theo phụ lục·Zybio Inc·Registered Jan 29, 2024

Registration details

Analysis ID: 240000162/PCBA-HN
Submission ID: 000.00.19.H26-240112-0021
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Zybio Inc
Manufacturer Country: Theo theo phụ lục
Product Owner: Zybio Inc
Authorized Representative: CÔNG TY TNHH THIẾT BỊ KHOA HỌC VIỆT ANH

Technical details

Intended Use: The kit used in in vitro diagnosis, which involves the pre-processing of pathogenic bacterial samples cultured from positive blood culture samples to support analysis and identification by mass spectrometry

Dates and status

Registration Date: Jan 29, 2024

About this record

Access comprehensive regulatory information for Kit for the preliminary processing of positive blood samples in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại A medical device is registered under number 240000162/PCBA-HN and manufactured by Zybio Inc. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ KHOA HỌC VIỆT ANH.

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