Vietnam MOH registration 2400650ĐKLH/BYT-HTTB

Linearization Control Material on the Test Strips and Glucose Meter

VN: Vật liệu kiểm soát tính tuyến tính trên các que thử và máy đo đường huyết

Vietnam·Risk Class TTBYT Loại C·ACCU-CHEK® Linearity Test Kit·Bionostics Inc·Registered May 10, 2024

Registration details

Analysis ID: 2400650ĐKLH/BYT-HTTB
Submission ID: 18007670/ĐKLH-BYT-TB-CT
Product Type: ACCU-CHEK® Linearity Test Kit
Product Code: 05048010001

Company information

Manufacturer: Bionostics Inc
Manufacturer Country: UNITED STATES
Product Owner: Roche Diabetes Care GmbH
Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

Technical details

Intended Use: The linear solution is used to test the linearity on the test strips and the dedicated blood glucose meter. It is intended for use by healthcare professionals to perform in-clinic tests on patients. It should only be used to test the linearity of the Accu‑Chek meters that use the Accu‑Chek Aviva, Accu‑Chek Performa, and Accu‑Chek Inform II test strips.

Dates and status

Registration Date: May 10, 2024

About this record

Access comprehensive regulatory information for Linearization Control Material on the Test Strips and Glucose Meter 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 2400650ĐKLH/BYT-HTTB and manufactured by Bionostics Inc. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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