Vietnam MOH registration 2403381ĐKLH/BYT-HTTB

Quantitative Blood Glucose Testing Control Material

VN: Vật liệu kiểm soát xét nghiệm định lượng đường huyết

Vietnam·Risk Class TTBYT Loại C·cobas® GLU QC kit·Bionostics Inc·Registered Nov 06, 2024

Registration details

Analysis ID: 2403381ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-231016-0028
Product Type: cobas® GLU QC kit
Product Code: 08275858190

Company information

Manufacturer: Bionostics Inc
Manufacturer Country: UNITED STATES
Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

Technical details

Intended Use: The cobas® GLU QC kit is used to assess the performance of the cobas®pulse quality control test using cobas® GLU test strips. The cobas® GLU QC kit is intended for in vitro diagnostic use and should not be used for self-testing.

Dates and status

Registration Date: Nov 06, 2024

About this record

Access comprehensive regulatory information for Quantitative Blood Glucose Testing Control Material 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 2403381ĐKLH/BYT-HTTB and manufactured by Bionostics Inc. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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