Vietnam MOH registration 230002385/PCBB-HN

IVD Red Blood Cell Lyse Solution for Hematology Analyzer

VN: IVD ly giải hồng cầu dùng cho máy phân tích huyết học
Vietnam flagVietnam·Risk Class TTBYT Loại B·Norma-iLyse5·Norma Instruments Zrt.·Registered Sep 25, 2023
Registration details
Analysis ID
230002385/PCBB-HN
Submission ID
000.00.19.H26-230920-0003
Product Type
Norma-iLyse5
Product Code
IC-21751
Company information
Technical details
Intended Use
Norma-iLyse5 is a stabilized and filtered lysing reagent designed to lyse red blood cells (RBC), thereby enabling the determination of the concentration of white blood cells (WBC), the differentiation of five types of white blood cells (LYM, MID, NEU, EOS, BAS), and the measurement of hemoglobin (HGB) concentration in human blood on the Norma Icon-5 hematology analyzer.
Dates and status
Registration Date
Sep 25, 2023
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About this record

Access comprehensive regulatory information for IVD Red Blood Cell Lyse Solution for Hematology Analyzer 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 230002385/PCBB-HN and manufactured by Norma Instruments Zrt..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Shanghai Kohden Medical Electronic Instrument Corp., and 2 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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