Vietnam MOH registration 240000048/PCBB-BYT

Magnesium (Mg) and Ammonia Electrolysis Drug Test Cluster IVD

VN: Cụm IVD thuốc thử điện giải Magie (Mg) và Ammonia

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Ortho-Clinical Diagnostics, Inc.·Registered Apr 03, 2024

Registration details

Analysis ID: 240000048/PCBB-BYT
Submission ID: 000.00.04.G18-240401-0005
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Ortho-Clinical Diagnostics, Inc.
Manufacturer Country: Theo theo phụ lục
Product Owner: Ortho-Clinical Diagnostics, Inc.
Authorized Representative: CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM

Technical details

Intended Use: The IVD drug test group for Magnesium (Mg) and Ammonia, consisting of the following components: (1) The quantitative Mg test slide (VITROS Chemistry Products Mg Slides): Used in in vitro diagnostic testing to quantitate the concentration of Magnesium (Mg) in serum, plasma, and urine on the VITROS 250/350/5,1 FS/4600/XT 3400 systems and the integrated VITROS 5600/XT 7600 systems. (2) The quantitative Ammonia test slide (VITROS Chemistry Products AMON Slides): Used in in vitro diagnostic testing to measure the concentration of ammonia in serum on the VITROS 250/350/5,1 FS/4600, XT 3400 systems and the integrated VITROS 5600/XT 7600 systems.

Dates and status

Registration Date: Apr 03, 2024

About this record

Access comprehensive regulatory information for Magnesium (Mg) and Ammonia Electrolysis Drug Test Cluster IVD in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240000048/PCBB-BYT and manufactured by Ortho-Clinical Diagnostics, Inc.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM.

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