Vietnam MOH registration 240000164/PCBA-HN

Virus Sample Pre-treatment Kit

VN: Bộ kit tiền xử lí mẫu vi sinh vật

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

Registration details

Analysis ID: 240000164/PCBA-HN
Submission ID: 000.00.19.H26-240119-0002
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: This kit is used for in vitro diagnosis and is used to process samples of microorganisms isolated from human samples (sputum, urine, feces, blood...) or samples amplified from the initial clinical sample (positive blood culture sample or positive urine sample) to support the analysis and identification by the mass spectrometry system.

Dates and status

Registration Date: Jan 29, 2024

About this record

Access comprehensive regulatory information for Virus Sample Pre-treatment Kit 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 240000164/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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