IVD Enzymes Cluster
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·I.S.E. S.r.l·Registered Aug 23, 2024- Analysis ID
- 240002126/PCBB-HN
- Submission ID
- 000.00.19.H26-240819-0023
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- I.S.E. S.r.l
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- I.S.E. S.r.l
- Authorized Representative
- CÔNG TY TNHH THƯƠNG MẠI KỸ THUẬT TPCOM
- 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.
- Registration Date
- Aug 23, 2024
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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.