Vietnam MOH registration 220001350/PCBA-HCM

IVD flow cytometry testing machine

VN: IVD kiểm tra máy xét nghiệm tế bào dòng chảy

Vietnam·Risk Class TTBYT Loại A·Count Check Beads green·Sysmex Partec GmbH·Registered Jun 21, 2022

Registration details

Analysis ID: 220001350/PCBA-HCM
Submission ID: 000.00.19.H29-220607-0033
Product Type: Count Check Beads green
Product Code: 05-4026

Company information

Manufacturer: Sysmex Partec GmbH

Technical details

Intended Use: Count Check Beads green is a concentrated, specialized solution used for quantitative calibration. It is recommended for daily calibration of the clinical flow cytometry cell counting machine Sysmex Partec, which is equipped with a green light excitation source. The product can be used immediately and loaded into the instrument through the sample port manually or through the automatic loading system. Count Check Beads green is a calibration material and does not provide any diagnostic information. Only laboratory technicians and trained FCM operators are permitted to handle Count Check Beads green.

Dates and status

Registration Date: Jun 21, 2022

About this record

Access comprehensive regulatory information for IVD flow cytometry testing machine in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại A medical device is registered under number 220001350/PCBA-HCM and manufactured by Sysmex Partec GmbH.

This page provides complete technical specifications, regulatory compliance details. 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.