IVD Enzymes Cluster - Vietnam Registration 230001483/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 230001483/PCBB-HN and manufactured by Theo theo phụ lục.

This page provides complete technical specifications, regulatory compliance details, 4 companies making similar products including Theo theo phụ lục, I.S.E. S.r.l, 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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230001483/PCBB-HN

Registration Details

Vietnam MOH Registration: 230001483/PCBB-HN

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Device Details

IVD Enzymes Cluster

VN: Cụm IVD Enzymes

Risk Class TTBYT Loại B

Registration Details

Analysis ID

230001483/PCBB-HN

Submission ID

000.00.19.H26-230629-0003

Product Type

Theo theo phụ lục

Product Code

Theo phụ lục

Technical Details

Intended Use

ADA: Used in in vitro diagnostic tests to quantify Adenosine deaminase in human serum or plasma AMYLASE -LQ: Used in in vitro diagnostic tests to quantify Amylase in human serum, plasma, or urine CK-NAC & CK-NAC –LQ: Used in in vitro diagnostic tests to quantify Creatine kinase in human serum or plasma CK-MB & CK-MB –LQ: Used in in vitro diagnostic tests to quantify Creatine kinase MB in human serum or plasma g-GT & g-GT –LQ: Used in in vitro diagnostic tests to quantify γ-glutamyltransferase in human serum or plasma GOT / AST & GOT / AST–LQ: Used in in vitro diagnostic tests to quantify Aspartate aminotransferase in human serum or plasma GPT/ ALT & GPT/ ALT: Used in in vitro diagnostic tests to quantify Alanine aminotransferase in human serum or plasma Lactate : Used in in vitro diagnostic tests to quantify Lactate in human serum or plasma LDH & LDH –LQ: Used in in vitro diagnostic tests to quantify Lactate dehydrogenase in human serum or plasma LIPASE –LQ: Used in in vitro diagnostic tests to quantify Lipase in human serum or plasma ALP/ & ALP- LQ: Used in in vitro diagnostic tests to quantify Lipase in human serum or plasma G-6-PDH : Used in in vitro diagnostic tests to quantify Glucose-6-Phosphate Dehydrogenase in human serum, plasma, or lung lavage fluid G-6-PDH CONTROL: Used to control the quality of the lactate dehydrogenase quantification in human serum, plasma, or lung lavage fluid ADA Calibrator: Used to calibrate the in vitro diagnostic test for quantifying Adenosine Deaminase in human serum or plasma. ADA Control: Used to control the quality of the in vitro diagnostic test for quantifying Adenosine Deaminase in human serum or plasma. CK-NAC / CK-MB CONTROL: Used to control the quality of the in vitro diagnostic test for quantifying Creatine kinase/ Creatine kinase MB in human serum or plasma. CK-NAC / CK-MB CONTROL low level: Used to control the quality of the in vitro diagnostic test for quantifying Creatine kinase/ Creatine kinase MB in human serum or plasma at low levels.