Vietnam MOH registration 240000827/PCBA-HN

Optical correction IVD and the liquid flow system on the flow cytometry testing machine

VN: IVD căn chỉnh quang học và hệ thống dịch lỏng trên máy xét nghiệm tế bào dòng chảy

Vietnam·Risk Class TTBYT Loại A·DxFLEX Daily QC Fluorospheres·Beckman Coulter, Inc.·Registered May 18, 2024

Registration details

Analysis ID: 240000827/PCBA-HN
Submission ID: 000.00.19.H26-240506-0010
Product Type: DxFLEX Daily QC Fluorospheres
Product Code: C39283

Company information

Manufacturer: Beckman Coulter, Inc.
Manufacturer Country: UNITED STATES
Product Owner: Beckman Coulter, Inc.
Authorized Representative: CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG

Technical details

Intended Use: DxFLEX Daily QC Fluorospheres are fluorescent micro-particles used to perform daily quality control of the optical alignment system and the liquid flow system of the DxFLEX cell flow cytometer. The product can also be used to support the calibration of the direct scatter, side scatter and fluorescence detection systems of the DxFLEX cell flow cytometer.

Dates and status

Registration Date: May 18, 2024

About this record

Access comprehensive regulatory information for Optical correction IVD and the liquid flow system on the 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 240000827/PCBA-HN and manufactured by Beckman Coulter, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG.

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.