IVD Enzyme Gamma Glutamyltransferase and Lipase - Vietnam Registration 240001023/PCBB-HN
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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Device Details
Registration Details
240001023/PCBB-HN
000.00.19.H26-240426-0010
Theo theo phụ lục
Theo phụ lục
Technical Details
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
May 09, 2024