Vietnam MOH registration 2300640ĐKLH/BYT-HTTB

Material for Quantitative Cell Population Testing CD3+/CD4+

VN: Vật liệu kiểm soát xét nghiệm định lượng quần thể tế bào CD3+/CD4+

Vietnam·Risk Class TTBYT Loại C·Pima™ Bead Standard·Abbott Rapid Diagnostics Jena GmbH·Registered Jun 20, 2023

Registration details

Analysis ID: 2300640ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-210820-0019
Product Type: Pima™ Bead Standard
Product Code: 260400011

Company information

Manufacturer: Abbott Rapid Diagnostics Jena GmbH
Manufacturer Country: GERMANY

Technical details

Intended Use: 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

Registration Date: Jun 20, 2023

About this record

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.

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