IVD Enzymes Cluster - Vietnam Registration 240002126/PCBB-HN

Access comprehensive regulatory information for IVD Enzymes Cluster 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 240002126/PCBB-HN and manufactured by I.S.E. S.r.l. The authorized representative in Vietnam is CÔNG TY TNHH THƯƠNG MẠI KỸ THUẬT TPCOM.

This page provides complete technical specifications, regulatory compliance details, 3 companies making similar products including Theo theo phụ lục, Theo phụ lục, and 5 recent registrations in the same category. 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.

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240002126/PCBB-HN

Registration Details

Vietnam MOH Registration: 240002126/PCBB-HN

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Device Details

IVD Enzymes Cluster

VN: Cụm IVD Enzymes

Risk Class TTBYT Loại B

Registration Details

Analysis ID

240002126/PCBB-HN

Submission ID

000.00.19.H26-240819-0023

Product Type

Theo theo phụ lục

Product Code

Theo phụ lục

Technical Details

Intended Use

- ALT / GPT: to determine the in vitro concentration of ALT / GPT in human serum or plasma. - AMYLASE: to determine the in vitro concentration of AMYLASE in human serum or plasma. - AST / GOT: to determine the in vitro concentration of AST / GOT in human serum or plasma. - CK-MB: to determine the in vitro concentration of CK-MB in human serum or plasma. - CK-NAC: to determine the in vitro concentration of CK-NAC in human serum or plasma. - GAMMA GT: to determine the in vitro concentration of GAMMA GT in human serum or plasma. - LDH-P: to determine the in vitro concentration of Lactate dehydrogenase in human serum or plasma. - LIPASE: to determine the in vitro concentration of LIPASE in human serum or plasma. - CK-MB Calibrator: to calibrate the concentration of CK-MB in the serum or plasma of patients. - CK-MB Control: to control the quality of the concentration of CK-MB in the serum or plasma of patients.