Vietnam MOH registration 240001002/PCBB-HN

IVD Enzymes Cluster: CK, Lipase, Amylase

VN: Cụm IVD Enzymes: CK, Lipase, Amylase

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Registered May 08, 2024

Registration details

Analysis ID: 240001002/PCBB-HN
Submission ID: 000.00.19.H26-240424-0010
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Authorized Representative: CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM

Technical details

Intended Use: (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

Registration Date: May 08, 2024

About this record

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.

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