Vietnam MOH registration 240002434/PCBA-HN

IVD Buffer Solution for In Vitro Diagnosis

VN: Cụm IVD Dung dịch đệm trong chẩn đoán in vitro

Vietnam·Risk Class TBYT Loại A·Theo theo phụ lục·Bio-Gram Diagnostics GmbH·Registered Oct 31, 2024

Registration details

Analysis ID: 240002434/PCBA-HN
Submission ID: 000.00.19.H26-241026-0008
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Bio-Gram Diagnostics GmbH
Manufacturer Country: Theo theo phụ lục
Product Owner: Bio-Gram Diagnostics GmbH
Authorized Representative: CÔNG TY TNHH GIẢI PHÁP THIẾT BỊ Y TẾ VIỆT NAM

Technical details

Intended Use: Used as a phosphate buffer according to WEISE to prepare the pH buffer solution. These pH buffer solutions are used in combination with other in vitro diagnostic medical devices to dye the test samples of human origin, which can be reproduced (capable of producing similar results in multiple tests).

Dates and status

Registration Date: Oct 31, 2024

About this record

Access comprehensive regulatory information for IVD Buffer Solution for In Vitro Diagnosis in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại A medical device is registered under number 240002434/PCBA-HN and manufactured by Bio-Gram Diagnostics GmbH. The authorized representative in Vietnam is CÔNG TY TNHH GIẢI PHÁP THIẾT BỊ Y TẾ VIỆT NAM.

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