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Material for Quantitative Cell Population Testing CD3+/CD4+ - Vietnam Registration 2300640ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Material for Quantitative Cell Population Testing CD3+/CD4+ in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2300640ĐKLH/BYT-HTTB and manufactured by Abbott Rapid Diagnostics Jena 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.

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2300640ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2300640ĐKLH/BYT-HTTB
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Device Details

Material for Quantitative Cell Population Testing CD3+/CD4+
VN: Vật liệu kiểm soát xét nghiệm định lượng quần thể tế bào CD3+/CD4+
Risk Class TTBYT Loại C

Registration Details

2300640ĐKLH/BYT-HTTB

000.00.04.G18-210820-0019

Pima™ Bead Standard

260400011

Company Information

Technical Details

Pima™ Bead Standard is an external control material used for daily quality control (QC) on the Pima Analyser and to monitor the setup and operation of the device and the analysis of data. It includes two ready-to-use test strips, the Pima Bead [Normal] and the Pima Bead [Low], with a predetermined number of fluorescent spots. Daily Quality Control (QC) must be performed before testing any patient samples or after moving the Pima Analyser. Each test takes approximately 7 minutes. For use in laboratory diagnosis.

Dates and Status

Jun 20, 2023