IVD Enzymes Cluster: CK, Lipase, Amylase - Vietnam Registration 240001002/PCBB-HN
Access comprehensive regulatory information for IVD Enzymes Cluster: CK, Lipase, Amylase 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 240001002/PCBB-HN. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM.
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.
Device Details
Registration Details
240001002/PCBB-HN
000.00.19.H26-240424-0010
Theo theo phụ lục
Theo phụ lục
Technical Details
(1) CK (IFCC): For use in in vitro diagnosis to quantify the activity of creatine kinase (ATP: Creatine N-Phosphotransferase (CK), EC 2.7.3.2) in human serum and plasma on the Thermo Scientific™ Indiko™ and Konelab™ instruments. All references to the Konelab system refer to the T series. (2) Lipase (Colorimetric): For use in in vitro diagnosis to quantify the activity of lipase (EC 3.1.1.3; triacylglycerol acylhydrolase) in human serum and plasma on the Thermo Scientific™ Indiko™ and Konelab™ instruments. All references to the Konelab system refer to the T series. (3) Amylase (IFCC): For use in in vitro diagnosis to quantify the activity of α-amylase (1,4-α-D-glucan glucanohydrolase, EC 3.2.1.1) in human serum, plasma and urine on the Thermo Scientific™ Indiko™ and Konelab™ instruments. All references to the Konelab system refer to the T series.
Dates and Status
May 08, 2024