Vietnam MOH registration 240001023/PCBB-HN

IVD Enzyme Gamma Glutamyltransferase and Lipase

VN: Cụm IVD Enzyme Gamma Glutamyltransferase và Lipase

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Ortho-Clinical Diagnostics, Inc.·Registered May 09, 2024

Registration details

Analysis ID: 240001023/PCBB-HN
Submission ID: 000.00.19.H26-240426-0010
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 Enzyme Gamma Glutamyltransferase and Lipase Assay Kit comprises the following components: (1) Gamma Glutamyltransferase Quantitative Assay (VITROS Chemistry Products GGT Slides): For in vitro diagnostic use to quantitate the activity of gamma glutamyltransferase (GGT) in serum and plasma on the VITROS 250/350/5,1 FS/4600/XT 3400 systems and the integrated VITROS 5600/XT 7600 systems. (2) Lipase Quantitative Assay (VITROS Chemistry Products LIPA Slides): For in vitro diagnostic use to quantitate the activity of Lipase (LIPA) in serum and plasma 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: May 09, 2024

About this record

Access comprehensive regulatory information for IVD Enzyme Gamma Glutamyltransferase and Lipase 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 240001023/PCBB-HN 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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